Why You Need Orthodontic Insurance Coverage

Why You Need Orthodontic Insurance Coverage

Insurance insures help patients when they want financial aid to obtain the needed service and have a difficulty. Such policies are used by them as a threat coverage tool, and one main policy folks take, is orthodontic insurance if they have been aware about their oral health. Correcting abnormalities and dental issues like misaligned or damaged teeth can improve grin and an individual’s facial features. Sadly, the prices can bite difficult in the lack of quality insurance. Dental treatment from Sky Orthodontist Oklahoma City changes among individuals so, the adolescents; therefore, many parents are under pressure in the adolescents who need to wear good looking braces.

Things become a lot simpler as the cover protects all processes and gear when you’ve got insurance insuring an orthodontist’s treatment. Check whether the policy contains coverage of treatment if you’ve got an existing dental insurance. Should it not have, then contemplate purchasing a supplementary form especially for this to cover your treatment prices. It’ll save you big time if you’ve got family members that want braces or treatment.

Just like your dental or insurance coverage that is routine, you’ll need to pay a monthly or annual premium. More than a few companies pay as much as fifty percent of the overall care expenses. So, if treatment is required by some of your nearest and dearest at once, your financial weight can ease significantly.

A bulk of the expenses come from the price of gear used in the restoration procedure like other additional dental products, braces, and retainers. The price of dental x rays, allowances that are needed, and monthly visits influence the amount being spent on treatment making it higher as opposed to dental care services that are routine. Averagely, the supplier to cater up to a specific quantity of dental care per year after which the maximum annual sum for all the dental prices become your company was just wanted by the typical dental cover.

In several cases, such processes are seen by individuals as being just decorative thus resulting in just several insurance companies providing cover for such a treatment services.

{ Comments are closed }

Is It Necessary To See A Dentist Frequently?

Is It Necessary To See A Dentist Frequently?

The prevention of periodontal disease, cavities, and bad breath is reached with oral direction techniques which are powerful and affordable, easy to perform on a daily basis. A professional should be consulted or more often depending on significant care attempts and dental demands. Dentist OKC offers complete oral health care services to patients to help in the care of a cavity grin that is free. Personal wellness techniques and advanced oral technology are supplied according to individual conditions.

The oral evaluation can discover changes and tooth issues in tissues indicative of major ailments including cancers and diabetes. Some of the most significant measures that people can take to maintain the healthy state of teeth would be to see with the dental offices frequently. A routine checkup contains the detection of tartar, plaque and cavities in charge of gum disease and tooth decay. The formation of a failure and bacteria can improve discoloration, oral deterioration and decay. A failure to correct oral issues including little cavities may lead to important destruction of tissue and enamel including tooth loss and acute pain.

A dentist will counsel patients on easy and affordable suggestions for health care care that is individual to grow strong teeth and gums. This can be a simple and affordable method shield the state of oral tissues and to prevent cavities. Specialized tools are integrated at the practice to supply a professional clean and accomplish places that cannot be reached with flossing and brushing. It shields against spots and decay that undermine the healthy state of pearly whites. A dental practice provides complete oral care helping in treating gum and tooth ailments. Meeting an oral professional often and following day-to-day hygiene measures can best protect and improve the state of your grin.

It is important to get it assessed time to time and to take good care of your dental health and stay healthy. Google “oral health”  if you want to learn more about the oral health.

{ Comments are closed }

Things To Look For In An Attorney Before Hiring Them

Things To Look For In An Attorney Before Hiring Them

Permit me to start by saying that do it yourself has its limitations. Certainly, contracts can be drafted by you by yourself, it is possible to survive discussions that are grotesque with your company customers, a married dispute can be settled by you but you should get an attorney when the demand to come to court appears. Expenses will be incurred, professional fees must be paid and the normally drawn-out procedure must be born. The prices of solving a difficulty are much greater in relation to the prices of preventing the issue. However, hiring a Sugar Land criminal defense attorney can eliminate the complexity, who knows what needs to be done.

When locating a lawyer so, search for a “competent” attorney. Before you start to share your innermost secrets together it’s absolutely ethical to require a lawyer permit. Generally though, their certifications would hang. He may be a professional in any among the following types of law: taxation law, labor law, civil law, international law, litigation, or criminal law. These are the important types. Therefore, you may learn of an immigration lawyer or a litigation attorney. Note however, that attorneys’ specialties are “obtained” through expertise, not only because they believe they have been excellent at it.

This can be one facet of being a lawyer where a youthful, inexperienced attorney can in fact get ahead of a seasoned one. Young attorneys usually are sympathetic, encouraging and lively. They have a tendency to treat their customers like their infants. They take care of every small detail, even the ones that are unimportant. But this just is paying customers desire to be treated. Customers often believe that they’re getting their money’s worth with the type of focus they can be becoming.

The personal qualities to try to find in an attorney depend significantly on the type of customer you might be. Should you be the no nonsense sort, you may choose to hire an old attorney who is about to retire. These kinds of attorney are interested in what you will need to say. Occasionally, they’re not thinking about what they must say. But their expertise is impeccable. The credibility of an attorney may be viewed in several circumstances. It can be built on charm coupled with referrals from previous satisfied customers. To be sure, no attorney can get customers if he’s not trustworthy and believable.

So at this point you have a credible, skilled and competent attorney having the individual qualities you try to find. Another matter to contemplate is whether that attorney can be acquired to attend to your own issue. Your attorney will say he is capable, willing and happy to help you. He said the identical thing to last week, and several others this morning, and the week. The point is, an attorney can only just do so much. He can not all be attending hearings all. He’d likely resort to rescheduling or cancelling hearings and assemblies that are significant to make ends meet. If your preferred attorney has a law firm, there will surely be other attorneys who can attend in case he is unavailable to you personally. You’ll find this satisfactory but not until your case continues to be reassigned to another from one hand.

The representation starts when you meet with your customer. This, nevertheless, isn’t what defines professionalism. So don’t be misled by the attorney-appear alone. It’d be amazing if your attorney can pull it away with the professionalism that is authentic and the attorney appearance though.

{ Comments are closed }

District Court Dismisses FTC Lawsuit Regarding Marketers of Prevagen; FTC Failed to Carry Burden

District Court Dismisses FTC Lawsuit Regarding Marketers of Prevagen; FTC Failed to Carry Burden

By Riëtte van Laack –
In January 2017, the Federal Trade Commission (FTC) and New York Attorney General (collectively, “Plaintiffs”) announced a lawsuit charging that Quincy Bioscience, related entities, and two individuals (collectively “Defendants”), the marketers of the dietary supplement Prevagen, made false and unsubstantiated claims that Prevagen improved memory.  Challenged claims included “Prevagen improves memory,” Prevagen “has been clinically shown to improve memory,” and the claim that “A landmark double-blind and placebo controlled trial demonstrated Prevagen improved short-term memory, learning, and delayed recall over 90 days.” Plaintiffs alleged that Defendants relied on a single study that failed to show that Prevagen works better that a placebo on any measure of cognition.
Defendants moved to dismiss the complaint on several grounds, including the argument that Plaintiffs’ Complaint failed to adequately allege that the advertising claims for Prevagen violate the FTC Act. On September 28, 2017, the District Court of the Southern District of New York granted the motion.
As described in the decision, Defendants claims were based on a clinical study that met the “gold standard,” i.e., a double blind, placebo controlled human clinical study using objective outcome measures using 218 subjects.” Plaintiffs did not take issue with the design of the study. However, they did take issue with the Defendants’ analyses of that study in support of its marketing claims. Namely, after the study failed to show a statistically significant improvement in the experimental group over the placebo group, Defendants conducted a “number” (more than 30) post hoc analyses of the results, looking at data for smaller subgroups. Doing so, they did find some statistically significant differences. These statistically significant results provided the basis for Defendants’ challenged marketing claims. Plaintiffs argued that this post hoc subgroup analysis did not constitute valid support for the claim because the post hoc analyses increased the probability of finding a significant improvement in a subgroup for one of the parameters. They argued that ‘[g]iven the sheer number of comparisons run and the fact that they were post hoc, the few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect.’ In other words, according to the Plaintiffs, the finding of a significant difference was merely the result of the number of analyses; if you throw a dice often enough, you will get the result you want.
The Court rejected Plaintiffs’ arguments, and concluded that their challenge to Defendants’ substantiation was theoretical. They had no evidence that the claim was not supported, but only showed there was a possibility that the study results did not support Defendants’ claims. This mere possibility rather than plausibility did not entitle Plaintiffs to relief.
Not surprising, FTC has not given much publicity to this loss. Plaintiffs may be considering whether to appeal the decision. We will be monitoring further developments.

{ Comments are closed }

50 Ways to Leave Your Lover and 56 Ways to Go to Jail

50 Ways to Leave Your Lover and 56 Ways to Go to Jail

By Robert A. Dormer –
Paul Simon sang about the 50 ways to leave your lover but there are more ways to go to jail if you are regulated by FDA. Congress has increased the regulatory powers of FDA significantly in the past 20 years but largely unnoticed has been the dramatic increase in criminal offenses under the Federal Food, Drug, and Cosmetic Act (FDC Act).  The relevant statutory provision is section 301 of the FDC Act which contains a list of prohibited acts, each of which is a potential criminal violation.  There are currently 56 subsections under 301, many of which contain multiple ways to violate the law.
As many well know the FDC Act is a strict liability criminal statute with respect to misdemeanor violations. That means that intent to violate the law is not required.  Subsection 301(a) is the quintessential criminal offense.  It makes illegal the “introduction or delivery for introduction into interstate commerce” of a food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.  That prohibition is bolstered by subsection (b) which makes it a crime to adulterate or misbrand any of these products while they are in interstate commerce, subsection (c) which makes it illegal to receive in interstate commerce adulterated or misbranded products and subsection (k) which makes it a crime to adulterate or misbrand a product after shipment in interstate commence.  These provisions have been at the core of FDA civil and criminal enforcement actions over the years.
When this law firm was started in March 1980 section 301 had 18 subsections — (a) through (r). In September 1980 Congress added subsection (s) which criminalized the failure to comply with requirements for infant formulas.  It was not until 17 years later that Congress completed the first alphabet by enacting subsections (x), (y) and (z) as part of the FDA Modernization Act.  Congress has been on a roll since, adding an entire second alphabet of criminal offenses — subsections (aa) through (zz) — in 11 years from 2000 to 2011.  Congress is now in the third alphabet.  The most recent addition is (ddd) which makes it illegal to manufacture or introduce or deliver for introduction into interstate commerce “a rinse-off cosmetic that contains intentionally added plastic microbeads.”  Who knew this was a problem worthy of Congressional action?  The legislative history shows that this prohibition is an environmental measure to address the presence of microbeads in the Great Lakes.
Many of these new criminal penalties were enacted as part of broader legislation that expanded FDA regulatory authority into new areas such as tobacco or enhanced the Agency’s powers, and correspondingly industry’s obligations, in areas that FDA has long regulated, such as food.
Among other prohibited acts is the “charitable contribution of tobacco products,” something that would have been welcomed by the troops serving in World War II, Korea, Vietnam and maybe even today in Iraq and Afghanistan. Another recent example is subsection (jj) which makes it illegal to fail to submit information on clinical trials to Clinicaltrials.gov.  Congress also significantly expanded the potential criminal liability of those in the food business.  Subsections (uu) through (zz) make criminal the failure to comply with very detailed and complicated requirements relating to food safety.  For example, the owner, operator or agent in charge of a facility is required to identify potential food safety hazards, institute preventive measures, monitor the effectiveness of those preventive measures and verify compliance, among other things.  A failure to do any of those things correctly is a criminal violation irrespective of intent.
As the Supreme Court said in 1943 in US v. Dotterweich, 320 U.S. 277 (1943) “Hardship there doubtless may be under a statute which thus penalizes the transaction though consciousness of wrongdoing be totally wanting.”  The potential for such hardship has increased dramatically since 1943 as Congress has expanded the scope of FDA’s authority and criminalized the inadvertent failure to comply with these wide-ranging regulatory requirements.  Although FDA and the Department of Justice have yet to bring prosecutions under most of these newer prohibitions, that should provide little comfort to those who work in FDA-regulated industries.

{ Comments are closed }

Flurry of New Guidances from CDRH and Notable Changes to the Pre-Submission Process

Flurry of New Guidances from CDRH and Notable Changes to the Pre-Submission Process

By Allyson B. Mullen –
Getting an early jump on winter, between September 29 and October 2, CDRH issued a blizzard of new guidance documents. All eleven of these guidances were issued based on commitments from MDUFA IV.  These guidances consist of:

four guidances regarding user fees for each type of submission (510(k)s, PMAs/BLAs, 513(g)s, and de novos); 
four guidances regarding administrative procedures and review time frames for premarket submissions (510(k)s, PMAs, de novos, and CLIA categorization);\
a guidance regarding responding to premarket submission deficiencies in a least burdensome manner (which we blogged on earlier here);
a revised guidance regarding 517A appeals; and
a revised pre-submission guidance.

A full list of the guidances can be found here.
The first eight guidances are mainly administrative and are consistent with the commitments described in MDUFA IV, which we summarized in our FDARA Summary. The revised 517A appeals guidance reflects the change from FDARA indicating that a substantive summary must now include an explanation regarding how the least burdensome requirements were considered and applied in the decision being appealed.  Given the boilerplate nature of least burdensome explanations, it is not clear that this will be of any real value.  In addition, the guidance adds that decisions regarding breakthrough decisions (granting/denial) are considered significant decisions, which can be appealed under Section 517A.
The revised pre-submission guidance has a few notable changes. These modifications primarily relate to meeting timing, scheduling of meetings, and meeting minutes.  The timeframe for most pre-sub types set forth in Table 1 of the guidance are unchanged.  However, consistent with MDUFA IV, the timeframe for general pre-submission has been modified.  Specifically, in the original 2014 guidance, FDA committed to having a meeting/teleconference (if requested) within 75 to 90 days from receipt of the pre-submission.  The guidance also committed to providing written feedback within 3 business days of the meeting/teleconference.  In the updated guidance, FDA now commits to generally holding meetings within 60 to 75 days of submission receipt and providing written feedback within 70 days of receipt or 5 calendar days prior to a meeting/teleconference, whichever is sooner.  The meeting timeframe is not much different from what was happening in practice prior to release of the new guidance.  In our experience, FDA has, when possible, been holding meetings within 60 to 75 days.  However, written feedback has sometimes been delayed, occasionally coming just a day before the meeting.  Receiving written feedback 5 calendar days before the meeting should allow submission sponsors more time to digest FDA’s written comments and prepare for their meetings.
The guidance also provides a more formalized process for scheduling pre-submission meetings. Sponsors will still need to propose three dates for a meeting/teleconference in its pre-submission.  Within 15 days of receipt, FDA will still conduct its acceptance review, which is unchanged.  Once accepted, FDA will either confirm one of the sponsor’s proposed dates or propose two alternative dates, which should be within 75 days of submission receipt.  FDA will work with the sponsor to set a meeting date between acceptance of the submission and 30 days after submission receipt.  If a meeting has not been scheduled by day 40, an FDA manager will call the sponsor to resolve the scheduling conflict.  In our view, this process was a much-needed addition to the guidance.  With all of its other obligations, FDA has sometimes fallen short on setting pre-submission meetings in a timely fashion.  We hope these new procedures will help facilitate timely meeting scheduling.
Another notable change is that the 2014 guidance said that an applicant could request the manner in which is preferred to receive feedback (i.e., meeting, teleconference, in writing). The guidance also said “please note that FDA will ultimately decide the means of communicating the feedback, but will consider the desired method requested in the Pre-Sub.”  This quoted language has been removed in the revised guidance.  While we are only aware of a couple of instances in which FDA did not provide the feedback in the manner requested by the sponsor, we are happy to see that this language has been removed.  The removal should mean that FDA will provide the type of feedback requested by the sponsor.
The final change relates to meeting minutes. The revised guidance indicates that at the beginning and end of a pre-submission meeting/teleconference, the sponsor must affirmatively state that it will draft minutes and provide meeting minutes to FDA within 15 calendar days of the meeting.  For those that have been to a pre-sub meeting recently, this is a statement that FDA typically makes at the start and end of the meeting.  Putting the responsibility on the sponsor may seem unusual; however, at the recent AMDM IVD Focus Meeting (October 5, 2017 in Los Gatos, CA), Elizabeth Hillebrenner, M.S.E., Associate Director for Programs and Performance at OIR indicated that FDA has had issues with pre-submission sponsors submitting meeting minutes.  Ms. Hillebrenner noted that issues generally include not submitting minutes at all, not submitting within 15 days, or submitting minutes that are inadequate to document the meeting (e.g., insufficient detail).  With this critique in mind, it makes sense that FDA would want manufacturers to acknowledge that they will draft and submit minutes within 15 days.  This procedural change should not be burdensome for sponsors.  Presumably, if a manufacturer forgets to make the requisite statement at the beginning and end, FDA will remind the company. 
Ms. Hillebrenner’s comments should also remind all pre-submission sponsors of best practices when it comes to meeting minutes. Sponsors should ensure that at least one person at the meeting is solely responsible for taking minutes.  The minutes should not be a transcript of the meeting.  However, they should be sufficiently detailed to document the discussion that occurred.  Well drafted meeting minutes benefit both the sponsor and FDA ensuring that there is an adequate, detailed account of the meeting.

{ Comments are closed }

Judicial Efficiency: DEA’s Expanding Use of Summary Dispositions to Narrow the Opportunity for an Administrative Hearing

Judicial Efficiency: DEA’s Expanding Use of Summary Dispositions to Narrow the Opportunity for an Administrative Hearing

By John A. Gilbert, Jr. & Andrew J. Hull –
There is a long history and established precedent in Drug Enforcement Administration (“DEA”) administrative cases in the use of summary dispositions (i.e., determination without a hearing) related to the loss of state licensing authority (e.g., state medical or controlled substance license) (see our previous post here). In such cases, agency precedent dictates that revocation is required as a matter of law. See Serenity Café, 77 Fed. Reg. 35027, 35027-28 (June 12, 2012).  In other words, because DEA views state licensure of practitioners to be a condition precedent to holding a DEA registration, a registrant without state licensure cannot, as a matter of law, continue to hold a registration. See 21 U.S.C. §§ 802(21), 823(f).
We previously commented on the fact that DEA had recently granted summary disposition in a case, Richard J. Blackburn, D.O., 82 Fed. Reg. 18669 (Apr. 20, 2017), involving, in part, an alleged material falsification of a DEA application for registration (see our previous post here). In our opinion, this was a troubling decision to expand the use of summary dispositions based on a factual issue and not as a matter of law, thus denying the registrant the opportunity to present evidence on the circumstances related to the allegation.
A more recent case, however, extends this trend and includes the apparent establishment of an “egregiousness” standard that DEA may use to justify future summary dispositions and, in the process, deny registrants the due process contemplated under the Controlled Substances Act (“CSA”) and regulations promulgated by DEA.
On October 5, 2017, DEA published a final order by the (now former) Acting Administrator revoking a physician’s registration through summary disposition. In this case, William J. O’Brien, III, D.O., 82 Fed. Reg. 46527 (Oct. 5, 2017), a physician had been convicted of over one hundred felony counts related to controlled substances, including one for distribution of controlled substances resulting in death.  The practitioner was sentenced to a total term of imprisonment of 30 years.  Not surprisingly, the state licensing authority also suspended his medical license (i.e., lack of state authority).
The government sought—and was granted—summary disposition on the lack of state authority. As noted above, this is a well established precedent.  However, the Acting Administrator also upheld the ALJ’s ruling granting the government’s motion for summary disposition on the felony conviction grounds.  In granting summary disposition on the felony conviction grounds, the ALJ noted the recent Blackburn decision in which the Acting Administrator held that the Government was entitled to summary disposition on the grounds of material falsification. 
This use of summary disposition based on a felony conviction related to a controlled substance (21 U.S.C. § 824(a)(2))—in our experience— is unprecedented and a trend that could lead to the erosion of the due process rights of DEA registrants and applicants.
The Acting Administrator acknowledged that the use of summary disposition was out of the ordinary:

In contrast to a practitioner’s loss of his state authority, this finding does not mandate the revocation of his registration on this ground [(i.e., felony conviction related to controlled substances)] and the Agency has held that a conviction is not a per se bar to registration (as is the loss of state authority). . . . Here, however, Respondent’s criminal conduct, which involves 120 felony convictions for unlawful distribution, including for unlawful distribution resulting in death, is so obviously egregious that revocation is warranted.

Id. at 46529. The Acting Administrator also admitted that “ordinarily a respondent who has been convicted of a felony subject to section 824(a)(2) is entitled to present a case as to why his registration should not be revoked (or his application denied).” Id.
However, the Acting Administrator appears to have created a new standard in stating that a hearing was unnecessary because the conduct was so “egregious.” While he noted that the practitioner had not alleged “evidence to show why he can be entrusted with a registration nor raised any contention that he acknowledges his misconduct and has undertaken remedial measures,” the physician never had the opportunity to hear or question the government’s case or to present actual evidence in his defense. Id. The bottom line:  DEA (government counsel, ALJ, and Acting Administrator) all agreed that the physician’s criminal convictions were so egregious that a hearing was useless.  In the Agency’s view, there was nothing that the physician could raise in his defense that could persuade the Acting Administrator against revocation.
The problem is that the CSA, DEA regulations, and DEA’s own precedent allow a respondent to rebut the government’s prima facie case by a showing of (1) acceptance of responsibility and (2) remedial actions. See, e.g., Mireille Lalanne, M.D., 78 Fed. Reg. 47750, 47777 (Aug. 6, 2013).  The respondent may also attempt to mitigate the severity of the wrongdoing by providing context, such as ill health or other circumstances.  Most importantly, the CSA states that, prior to revoking a registration based on a violation of 21 U.S.C. 824(a) (including felony conviction related to controlled substances), the Administrator must provide the respondent with an opportunity for a hearing under the Administrative Procedure Act (“APA”). See 21 U.S.C. § 824(a)(c).
DEA’s failure to provide the physician in this case with an opportunity for a hearing to present testimony and/or documentary evidence on the felony conviction grounds (21 U.S.C. § 824(a)(2)) flies in the face of the due process protections afforded to respondents by the APA and CSA. It also deviates from other cases where DEA did afford the respondents the opportunity for a hearing even though they had been convicted of felonies related to controlled substances.  In some of these cases, DEA refused to revoke a registration (or deny an application) in light of the respondent’s remedial case, despite a finding that the respondent has been convicted of a felony related to controlled substances. See, e.g., Kimberly Maloney, N.P., 76 Fed. Reg. 60922, 60922-23 (Sept. 30, 2011) (granting application of physician with felony conviction for obtaining controlled substance by means of forged prescription); Michael S. Moore, M.D., 76 Fed. Reg. 45867, 45867-68 (Aug. 1, 2011) (suspending—not revoking—registration of doctor convicted of felony manufacturing of controlled substance); Mary Thomson, M.D., 65 Fed. Reg. 75969, 75971-52 (Dec. 5, 2000) (continuing registration with restrictions of physician with felony conviction for obtaining controlled substances by fraud); Edson W. Redard, M.D., 65 Fed. Reg. 30616, 30618-19 (May 12, 2000) (continuing registration with restrictions of physician with felony conviction for obtaining controlled substance by fraud).
DEA’s decisions in this case and the Blackburn case reveal a troubling trend.  The Agency has now provided some precedent for obtaining a revocation or application denial through summary disposition based on grounds other than loss of state authority (so far, material falsification and felony conviction)—grounds that are by statute to be reviewed (at the request of the respondent) through the hearing process.  21 U.S.C. § 824(c).  Now it appears DEA may decide that the alleged violations are so “egregious” that it need not provide the required due process rights.  So, for example, DEA could decide that a registrant’s recordkeeping is so deficient on its face and as a matter of law, that the registrant should not be given the opportunity to present evidence in his/her defense or to accept responsibility and demonstrate remedial action.  
In conclusion, as required by law and agency precedent, DEA should limit summary dispositions to matters of law with no factual dispute. Otherwise, despite potentially  “egregious” actions, registrants should be provided the due process required under the law, regulations, and agency precedent. 

{ Comments are closed }

California Enacts Law to Increase Drug Pricing Transparency

California Enacts Law to Increase Drug Pricing Transparency

By McKenzie E. Cato*, David C. Gibbons & Michelle L. Butler –
On October 9, 2017, California Governor Jerry Brown signed into law a bill (SB 17), which imposes new notification and reporting requirements on pharmaceutical companies, health care service plans, and health insurers. Among the many reporting obligations under SB 17, we describe below only those obligations associated with drug pricing. Other state legislatures have undertaken similar efforts intended to promote transparency in drug pricing (see our posts on a Nevada bill, here, and a Vermont law, here). Maryland enacted a law that prohibits an “unconscionable increase” in the price of a generic drug, which is the subject of ongoing litigation (see our posts here and here).
Manufacturer Reporting: WAC Increases of 16% or More
Pharmaceutical manufacturers with prescription drugs purchased or reimbursed by a state purchaser, licensed health care service plan, health insurer, or pharmacy benefit manager (PBM) have reporting requirements under SB 17. It is important to note that, under California law, manufacturers include not only those entities that produce prescription drugs, but also those that repackage prescription drugs as well as certain types of entities that distribute those drugs. See Cal. Bus. & Prof. Code § 4033. A manufacturer with any prescription drugs that have a wholesale acquisition cost (WAC) of more than $40.00 for a course of therapy must notify each purchaser if it will increase the WAC more than 16%. The 16% increase threshold includes the current increase and the cumulative increases that occurred within the previous two calendar years prior to the current year. Notice must be given to the purchaser at least 60 days prior to the planned effective date of the increase. PBMs receiving notice of WAC increases greater than 16% must notify their contracted large public and private purchasers (covering >500 lives) of such increases as well. California’s Office of Statewide Health Planning and Development (OSHPD) Legislative Affairs office indicated that the effective date for these notification requirements and other requirements which do not specify a delayed implementation date is January 1, 2018.
Starting in January 2019, prescription drug manufacturers must report to the OSHPD on a quarterly basis the following information for each drug with an increase in WAC of over 16%:

A description of the financial and nonfinancial factors used to make the decision;
A schedule of WAC increases for the drug for the previous five years;
If the drug was acquired by the manufacturer in the last five years, other information about the WAC history, purchase price, and the previous owner;
Patent expiration information;
Whether the drug meets the definition of multiple source drug, innovator multiple source drug, noninnovator multiple source drug, or single source drug under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8(k)(7)(A));
A description of the “change or improvement in the drug, if any, that necessitates the price increase”; and
The volume of U.S. sales for that drug in the previous year.

Manufacturer Reporting: New Drugs
If a prescription drug manufacturer plans to introduce a new prescription drug to market at a WAC that exceeds the threshold set for a specialty drug under the Medicare Part D program, it must notify OSHPD in writing within three days after release of the drug in the commercial market. The specialty tier threshold for Calendar Year (CY) 2017 (and CY 2018) is $670 per month. CMS, Announcement of CY 2018 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter and Request for Information, 152-153 (Apr. 3, 2017).
The notification must include the following information:

A description of the marketing and pricing plans used in the launch of the new drug in the United States and internationally;
The estimated volume of patients who may be prescribed the drug;
Whether the drug was granted breakthrough therapy designation or priority review by FDA prior to final approval; and
The date and price of acquisition if the drug was not developed by the manufacturer.

Additional Manufacturer Reporting Provisions
OSHPD will publish the information obtained under the two sections above on its website at least quarterly. SB 17 states that the “information shall be published in a manner that identifies the information that is disclosed on a per-drug basis and shall not be aggregated in a manner that would not allow identification of the drug.”
Manufacturers may limit the information reported under the two sections described above to information that is otherwise in the public domain or that has been made publicly available.
Finally, manufacturers may incur civil penalties of $1,000 per day following the notification period for noncompliance.
Health Insurer and Health Plan Reporting Related to Prescription Drugs
With regard to health insurers and health care service plans that must, under California law, report rate information to either the state Department of Managed Health Care (DMHC) or Department of Insurance (DOI), SB 17 requires reporting to DMHC or DOI the following cost information for all covered prescription drugs no later than October 1 of each year, starting in 2018:

The 25 most frequently prescribed drugs;
The 25 most costly drugs by total annual plan spending; and
The 25 drugs with the highest year-over-year increase in total annual plan spending.

DMHC and DOI must compile this information into a public report “that demonstrates the overall impact of drug costs on health care premiums.” The report must be published on their websites by January 1 of each year.
SB 17 also requires health plans with large group health care service plan contracts and health insurers with large group health insurance policies to disclose the following information for covered generic, brand, and specialty drugs dispensed at a plan, network, or mail order pharmacy for outpatient use:

The percentage of the premium attributable to prescription drug costs for the prior year for each prescription drug category;
The year-over-year percentage increase in per-member, per-month total health plan spending for each prescription drug category;
The year-over-year increase in per-member, per-month costs for drugs, compared to other components of the health care premium;
The specialty tier formulary list;
The percentage of the health care premium attributable to prescription drugs covered under the medical benefit;
Information on the use of a PBM, if any, along with information on which components of prescription drug coverage are managed by the PBM; and
The PBM or other manager name(s).

We will continue to track implementation of SB 17 and similar legislation regarding drug pricing transparency in other states.
* Law Clerk

{ Comments are closed }

A Spark Points the Way Forward on Gene Therapy

A Spark Points the Way Forward on Gene Therapy

By Frank J. Sasinowski & James E. Valentine –
Today (October 12, 2017) FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously recommended approval of Spark Therapeutics, Inc.’s Biologics License Application (BLA 125610) for Voretigene Neparvovec (also called LUXTURNA), a gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy (i.e., an inherited retinal dystrophy that always progresses to blindness). This is the first true gene therapy to come before an FDA advisory committee.  Today’s action boosts not only the hopes of those with this specific genetic disorder, but also sparks hope among all those with incurable genetic diseases.
“Lessons Learned” include:

A single pivotal efficacy study of modest scope (n=31) may be sufficient.
Dose optimization and drug safety assessments, even for highly innovative gene therapy, need not be necessarily more extensive than those for other similarly rare diseases.
Videographic evidence of subjects negotiating a dimly-lit maze shows sponsor and FDA commitments to preference for a patient-centric primary endpoint measure.
This measurement of a critical daily patient function is even more noteworthy here in this clinical area that has very well established quantitative measures (e.g., visual acuity and visual field which were secondary endpoints).

Global Observation:
The Office of Tissues and Advanced Therapies within the Center for Biologics Evaluation and Research at FDA exhibits reasonable and appropriate “flexibility” in its review of this first true gene therapy seeking FDA registration.
Today’s action may be the Spark that illuminates the way forward for all those with incurable genetic disease.

{ Comments are closed }

FDA Updates “Least Burdensome” Guidance After 17 Years

FDA Updates “Least Burdensome” Guidance After 17 Years

By Adrienne R. Lenz –
Sponsors commonly receive a request for additional information (AI) during Food and Drug Administration (FDA) review of a 510(k) submission, de novo classification request, or premarket approval application. In some cases, a sponsor may conclude that one or more AI requests calls for information that is not relevant or necessary to fulfill the statutory criteria for clearance or approval. Such requests do not comply with the requirement in the Federal Food, Drug, and Cosmetic Act for FDA to require the “least burdensome” scientific evidence necessary to support clearance or approval.
In these situations, a useful first step is to turn to FDA’s guidance, Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions – Guidance for Industry and Food and Drug Administration Staff. An updated version of this guidance was issued on September 29, 2017, in fulfillment of a Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. It aims to help FDA review staff and supervisors request additional information that represents the “minimum required” to make their regulatory decisions. See FD&C Act, Sections 513(i)(1)(D)(ii), 513(a)(3)(D)(iii), and 515(c)(5)(B).
The guidance was originally issued 17 years ago (on November 2, 2000). It applies to FDA’s requests for additional information, which they refer to as deficiencies, needed to complete reviews of premarket approval (PMA), humanitarian device exemption (HDE), premarket notification [510(k)] and De Novo premarket submissions. As in the original, the guidance sets forth principles for FDA in writing deficiency letters and provides a suggested format for industry responses to FDA deficiencies. A sponsor can use these principles when explaining to FDA why a particular AI request is not “least burdensome.”
New to the guidance are a set of six guiding principles for FDA review staff:

Information unrelated to the regulatory decision should not be part of the decision-making process.
Alternative approaches to resolving regulatory issues should be considered to optimize the necessary time, effort, and resources involved in developing a response.
Deficiencies should request the minimum (i.e., least burdensome) amount of information necessary to adequately address the identified issue in the most efficient manner at the right time. The balance between premarket and postmarket should be considered to determine when information should be provided to address the identified issue.
Major deficiencies are those based on least burdensome principles that, if not resolved, will preclude a favorable decision on the marketing application. Major deficiencies should only be included if their resolution is necessary in order to reach a final decision regarding the marketing authorization.
If the Agency is including minor deficiencies identified during the review in the deficiency letter, the Agency should identify these requests separately from major issues, and whenever possible, attempt to resolve minor questions/issues interactively. Minor deficiencies are FDA requests that can be resolved in a straightforward manner, but that need to be addressed to meet regulatory requirements or to prevent potential misbranding or adulteration. In general, the Agency should not issue a formal deficiency letter if only minor deficiencies remain, but instead should attempt to resolve them interactively.
FDA may also include additional considerations that are suggestions, recommendations, or requests that are not expected to preclude a favorable decision on the marketing application. Because additional considerations are not expected to preclude a favorable decision, they do not require an applicant response.

Also new is the requirement from the MDUFA IV Commitment Letter for all deficiency letters to undergo supervisory review prior to issuance. Additionally, the recommendation for FDA staff now includes the following: “where appropriate, reference to an applicable section of a final rule, final guidance, and/or an FDA recognized standard (unless the entire or most of the document is applicable). When the deficiency cannot be traced in the manner above and relates to a scientific or regulatory issue pertinent to the determination, FDA will cite the specific scientific issue and the information to support its position.”
Like the original guidance, the updated guidance provides a recommended format for responding to deficiencies. These recommendations include:

1. Restate the identified Agency issue; and
Provide one of the following:
the information or data requested;
an explanation why the issue is not relevant to the marketing authorization decision; or
alternative information and an explanation describing why the information adequately addresses the issue.

One of the biggest challenges in responding to an FDA deficiency letter is persuading FDA to actually accept to accept either alternative information or a sponsor’s explanation as to why additional information is not necessary. These are areas where sponsors and reviewers often struggle to reach agreement. Although some examples are provided, the new guidance provides no new insights on how best to approach this perennial problem. In our experience, the most persuasive case will be based on a deep understanding of the technology and careful attention to the concern FDA is raising. Simply reiterating the “least burdensome” mantra back to FDA reviewers is unlikely to yield positive results.
All in all, while the “least burdensome” requirement has never had a lot of teeth in it, we are hopeful that the new guiding principles, specific references and supervisory review will help keep FDA’s deficiency letters focused on the minimum information necessary to reach a regulatory decision.

{ Comments are closed }

CMS Abandons Pilot Program to Test Alternative Drug Payment Models Under Medicare Part B

CMS Abandons Pilot Program to Test Alternative Drug Payment Models Under Medicare Part B

By McKenzie E. Cato* & David C. Gibbons –
In early 2016, CMS issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B (see our previous post here). The current statutory payment methodology for most drugs under Medicare Part B is the Average Sales Price (ASP) plus six percent. The proposed five-year pilot program would have tested an alternative payment methodology of ASP + 2.5% plus a flat fee of $16.80 (Phase I) and the effect of four different value-based pricing methods (Phase II). The pilot was to have been conducted under the authority of Section 1115A of the Social Security Act, which authorizes CMS’s Center for Medicare and Medicaid Innovation (CMMI) to test innovative payment models to reduce program expenditures.
On October 4, CMS announced, in a short Federal Register notice, that it has withdrawn the proposed rule. The notice states that the Agency received 1,350 public comments and that “a number of commenters expressed concerns about the proposed model.” Because of the “complexity of the issues related to the proposed model design and the desire to increase stakeholder input,” CMS decided to abandon the proposed pilot. The notice concludes with a statement about how the Agency wants to “ensure agency flexibility” in re-examining these issues.
We will continue to track this and any new initiatives concerning drug payment methodology proposed under CMMI.
* Law Clerk

{ Comments are closed }

OIG Report on FDA’s Inspections of Domestic Food Facilities: Challenges Remain

OIG Report on FDA’s Inspections of Domestic Food Facilities: Challenges Remain

By Riëtte van Laack –
On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on FDA’s domestic food facility inspections.  The “key takeaway”: “FDA should do more to ensure that the food supply is safe by taking swift and effective action to ensure the prompt correction of problems identified at domestic food facilities.”
In the previous (2010) review, OIG found that FDA inspected less than a quarter of domestic food facilities each year, and that many facilities had not been inspected in 5 years or more. OIG also found that FDA did not always take action against facilities with significant inspection violations or take steps to ensure the violations were corrected. According to the 2017 OIG report, two key recommendations from OIG’s 2010 review remain outstanding, i.e., (1) take appropriate action against facilities with significant inspection violations and (2) ensure that those facilities correct the violations.
FSMA requires FDA to increase the frequency of its inspections of domestic food facilities. Specifically, FSMA mandates that FDA inspect high-risk facilities at least once during the initial 5-year inspection cycle and then at least once every 3 years for subsequent cycles. (A facility would be high risk based on a number of factors including association with outbreaks, recalls or prior food safety related violations.) For the remaining facilities, the non-high risk facilities, FSMA requires that FDA inspect them at least once during the 7-year initial inspection cycle and at least once every five years for subsequent cycles. Prior to FSMA, there were generally no timeframes for food facility inspections.
While executing its inspection plan, FDA discovered that information about food establishments was not always up-to-date or sufficient. For a not-insignificant percentage (more than 25%) of the facilities, FDA’s inspection failed because the facility was either out of business or otherwise not in operation at the time of the visit. These failed inspections were counted as completed inspections. OIG determined that FDA has no policy to assure that such inspections do occur.
OIG determined that FDA is on track to meet the requirements for the first round of inspections (for the high risk facility inspections, FDA is in fact ahead of the schedule as it completed inspections for almost all those facilities within three years). FDA likely can meet the requirement for the second round of inspections of the high-risk facilities (to be completed within three years). However, OIG questions the Agency’s ability to meet the second (5-year) inspection cycle for the non-high-risk facilities.
OIG further determined that FDA uncovered significant (official action indicated or OAI) violations in one to two percent of the inspected facilities. In 22% of those instances, FDA allegedly did not take any action. Moreover, in the instances that FDA did take action, FDA “commonly relied on facilities to voluntarily correct [the] . . . violations” in response to a Warning Letter, Untitled Letter or similar action by FDA. According to OIG, FDA actions were “not always timely.” In the period from 2011 to 2015, FDA took 1,113 “advisory actions” consisting of 903 warning letters, 136 regulatory meetings, and 74 “untitled letters.” Those actions were taken (on average) 4.4 (warning letters and meetings) to 6.1 months (untitled letters) after an inspection.
OIG further determined that in the five-year period, FDA ordered a suspension of a food facility twice (0.8 months after the inspection) and five administrative detention orders (0.2 months after the inspection). FDA sought judicial action 58 times, and won seizure orders in 21 instances. OIG noted that FDA did not use its mandatory recall authority. Of course mandatory recall is not needed if companies recall products when asked by FDA.
For almost 50% of the OAI inspections, FDA did not conduct a follow-up inspection within 1 year and for 17% of the OAI inspections, FDA did not conduct a follow-up inspection of the facility at all. In cases that FDA did a reinspection, one in five facilities received a second OAI classification. Three quarters of these second OAI classifications involved the same problem that caused the first OAI classification.
OIG recommend that FDA:

improve how it handles attempted inspections to ensure better use of resources;
take appropriate action against all facilities with significant inspection violations;
improve the timeliness of actions, including warning letters; and
conduct timely follow-up inspections to ensure that significant inspection violations are corrected.

FDA’s written responses and explanations are in the OIG report. FDA generally concurs with the OIG recommendations.
A major goal of FSMA is to be preventive rather than reactive. During the five-year period studied by OIG, the majority of food facilities were not yet subject to the preventive control regulations. It will be interesting to see how the implementation of these requirements affects FDA inspections and compliance.

{ Comments are closed }

FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

By McKenzie E. Cato* & Allyson B. Mullen –
In July of last year, FDA released a draft guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies (see our post on the draft guidance here). On September 12, 2017, FDA released the final version of this guidance.
The stated objectives of the guidance are to:

Encourage the collection and consideration during the study design stage of relevant age, race, ethnicity, and associated covariates for devices for which safety, effectiveness, or benefit-risk profile is expected to vary across these groups;
Outline recommended analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes; and
Specify FDA’s expectations for reporting age-, race-, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices.

This guidance is intended to extend and complement two earlier guidance documents on sex, race, and ethnicity data: Evaluation of Sex-Specific Data in Medical Device Clinical Studies (Dec. 2011) and Collection of Race and Ethnicity Data in Clinical Trials (Sept. 2005). 
The guidance emphasizes that when “clinically relevant differences in treatment effect are anticipated across age, racial, or ethnic groups,” sponsors should consider proper clinical study design, proper enrollment of subgroups, and control of study-wise Type 1 error for overall and subgroup-specific hypothesis testing.” To that end, the guidance outlines specific recommendations for achieving appropriate enrollment; considering age, race, and ethnicity in study design, analysis, and interpretation of study results; and submitting age-, race-, and ethnicity-specific data in submissions to FDA and reporting in public documents.
The content of the final guidance document is largely unchanged compared to the draft guidance (outlined in detail in our previous post here). However, FDA was very responsive to suggested revisions from industry and other non-profit groups submitted to the Agency in comments on the proposed draft guidance.
The Association of American Medical Colleges (AAMC) suggested additions to the guidance’s section on study design and the early enrollment stage. In particular, they suggested additional recommendations to enhance enrollment of relevant age, racial, and ethnic subgroups, such as creating materials appropriate for low-literacy populations, utilizing communication through electronic means and social media, and working with minority health professional organizations and patient advocacy groups. FDA incorporated all of these suggestions for enhanced enrollment strategies.
The Advanced Medical Technology Association (AdvaMed) made several specific suggestions, which FDA incorporated in the final guidance. For example, AdvaMed suggested that FDA delete a subsection titled “Special Study Design Considerations for Diagnostic Devices” because “[i]t is unclear why special study design considerations would only apply to diagnostic devices.” FDA took AdvaMed’s advice, and this subsection does not appear in the final guidance. Additionally, AdvaMed suggested that FDA state that hypotheses for exploratory (i.e., post-hoc) analyses should be consistent with the literature of the natural history of the disease and its prevalence in subgroups or be consistent with the known pathophysiology. The final guidance includes this statement in a section on interpretation of age-, race-, and ethnicity-specific data.
The 510(k) Coalition, which is a coalition of medical device companies, stated in its comment on the draft guidance that it would like clarification on whether a company should submit modified labeling if it determines post-clearance or approval that there are clinically meaningful age-, race-, and/or ethnicity-specific differences in disease course, outcomes, or benefit-risk profile. FDA added a statement to the guidance encouraging the use of postmarket data to “modify labeling to support additional information regarding device safety or effectiveness and/or to clarify how the device should be used.”
MED-EL, a manufacturer of implantable hearing systems, pointed out that FDA used an outdated example in its discussion of why it is important to consider age-specific differences. In the draft guidance, FDA stated that the use of cochlear implants in certain pediatric subgroups may not be advisable due to the size of the implant or may be inappropriate due to the stage of neurological development of the child. MED-EL explained in its comment that the cochlear implants it manufactures are indicated for patients one year of age or older. As a result, FDA did not include this example in the final guidance.
At least two groups (AAMC and Bridge Clinical Research) stated in their comments on the draft guidance that FDA should use stronger language in the guidance or promulgate regulations regarding increased diversity in clinical trials. For example, AAMC recommended that FDA suggest all studies consider collection of age, race, and ethnicity data, not solely those for which subgroup differences are anticipated. FDA did not appear to revise the guidance to include stronger language or suggest the possibility of future rulemaking on this topic. The requested expansion by AAMC could have presented a significant burden for devices in which there is no potential for differences in age, race, and ethnicity.  
Two groups, the Patient, Consumer, and Public Health Coalition and the National Women’s Health Network recommended that FDA create an equivalent program to FDA’s “Drug Trials Snapshots” program for devices. FDA’s Drug Trials Snapshots summarize information about the demographics of people who participate in drug clinical trials and highlight whether there were any differences in benefits and side effects among sex, race, and age groups. FDA did not mention the possibility of creating a similar program for devices in the final guidance, but it will be interesting to see whether FDA makes device clinical trial demographic information available to the public in the future as a way to encourage compliance with the guidance. Certainly on the diagnostic side, we may see FDA expressly include this type of information in its decision summaries posted on FDA’s website.
* Law Clerk

{ Comments are closed }