New Legislation Seeks Limits on Opioid Prescriptions for Acute Pain, But Will it Reduce Opioid Abuse?

New Legislation Seeks Limits on Opioid Prescriptions for Acute Pain, But Will it Reduce Opioid Abuse?

By James R. Phelps –
The scourge of opioid addiction has received considerable attention for some time, and now legislation is proposed to address the overuse of addictive prescription opioids: Senate bill 892, the Opioid Addiction Prevention Act of 2017. The proposed legislation defines conditions of acute pain and tells physicians how they may prescribe for them.
This bipartisan bill, offered by Senator John McCain (R-AZ) and Senator Kirsten Gillibrand (D-NY), would require physicians who prescribe opioids to certify, in order to secure registration or renewal of registration under the Controlled Substances Act, that they would, to treat acute pain, not write a prescription for more than a 7-day supply of an opioid. Further, the bill prohibits the refill of such prescriptions for acute pain. It does appear that the bill would not prohibit a physician to treat acute pain that lasts for more than 7 days by issuing serial 7-day,but nonrefillable prescriptions.
If there are other limitations on prescribing for acute pain imposed by the states, those limitations would be given force by this the bill.
“Acute pain” is defined as “pain with abrupt onset and caused by an injury or other process that is not ongoing.” The bill excludes from the meaning of “acute pain” the following: “chronic pain,” “pain treated as part of cancer care,” “hospice or other end-of-life care,” or “pain treated as part of palliative care.” Further, the prescribing limitations of the bill do not apply to prescriptions of Schedule II, III, or IV opioids intended and used to treat addiction.
Navigating treatment of patients in compliance with federally-prescribed diagnoses of pain will be the responsibility of the physicians. The bill defines acute pain as pain from a particular source — an injury or other process that is not ongoing — but it makes no attempt to say how much the pain must hurt to be “acute;” that is evidently left to the doctor. Further, when a “process is not ongoing” could be hard to know — consider the pain following surgeries; if the process of healing is “not ongoing” pain, then the scripts need to be issued every 7 days.
Given that the bill does not limit the number of 7-day scripts the doctor might write, it can be assumed that its intent is to require weekly patient/doctor interaction. The need for that, and its effect upon the patients and their physicians, needs study; perhaps the medical profession can best determine what is good medical practice.
The bill gives a clear signal that members of Congress are deeply concerned about opioid addiction, and they are to be commended. How much it might do to reduce the abuse of opioids is questionable.

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Congress Releases a (Near) Clean Draft User Fee Bill; Includes Restructured Assessment of Fees & Very Limited Policy Riders

Congress Releases a (Near) Clean Draft User Fee Bill; Includes Restructured Assessment of Fees & Very Limited Policy Riders

By James E. Valentine –
On April 14, 2017, Congress released a discussion draft of a bill to reauthorize the FDA’s various user fee programs, commonly referred to as “the UFAs.” The FDA Reauthorization Act (FDARA) would renew the Agency’s authority to collect user fees in Fiscal Years 2018 through 2022 and put into effect the commitments negotiated by FDA and regulated industry, which are proposed in the following commitment letters:

PDUFA VI
MDUFA IV
GDUFA II
BSUFA II

Without such legislative action, the authority to collect user fees is set to expire on September 30th. In fact, if the user fee programs aren’t reauthorized before August, FDA will have to send layoff notices to more than 5,000 employees whose positions are supported through user fee funds – and if not enacted, or not in a timely manner, it would cripple the Agency’s drug and device review functions. However, it appears both the Senate and House are interested in a timely reauthorization, with Energy and Commerce Committee Chairman Greg Walden (R-OR) stating that the House is “fully committed to a timely reauthorization of the agreements” and Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) stating “the sooner we reauthorize the agreements the better.”  The full text of the FDARA discussion draft is available here.
A “Clean” User Fee Bill
The most noteworthy aspect of FDARA is what is not included: a litany of policy proposals tacked onto the core user fee reauthorization language. This is counter to what we have come to expect, with the 156 page FDAAA in 2007 and the 140 page FDASIA in 2012 – FDARA is all of 34 pages. This means it includes very minimal provisions that go beyond the language needed for FDA to collect user fees and report on performance and finances, including updating base fee amounts and workload/capacity adjustments.
In addition to potential expediency of passing this proposed legislation that is supported in a bipartisan manner, another possible reason that Congress is interested in a clean bill is that it just had an opportunity to pass comprehensive FDA reform legislation with the 21st Century Cures Act, which was signed into law in December of 2016 (see our summaries of 21st Century Cures here, here, here, and here).
With that being said, there are a number of reforms to the structures of how fees are assessed, as well as a limited number of policy riders, which are discussed in turn below.
Restructuring the User Fee Programs
Under PDUFA VI, FDARA would change the historical structure where prescription drug user fees were derived one-third from facility fees, one-third from various application fees, and one-third from product fees. The new structure would collect 20% from application fees and 80% from fees for approved products, with fees for supplemental applications and facilities being eliminated.
Meanwhile, MDUFA IV would add a user fee for de novo classification requests, which makes sense since there was no apparent reason for an exemption for this type of application, which has grown in popularity.
GDUFA II would eliminate prior approval supplement and establish a generic drug applicant program fee. This program fee would be based on how many ANDAs the applicant has approved by FDA (tiered by 20+ paying the full fee, 6-9 paying 40% of the fee, and 1-5 paying 10% of the fee). Ultimately, 33% of total generic drug user fees will come from application fees, 20% from generic drug facility fees, 7% from API facility fees, and 35% coming from this new program fee.
Finally, BSUFA II would establish a fee structure for biosimilars as follows: (i) Initial Biosimilar Development Fee for the 1st year of clinical development, (ii) Annual Biosimilar Development Fee for subsequent years of clinical development, (iii) Biosimilar Program Fee for sponsors of approved biosimilars, and (iv) Application Fee for new biosimilar applications (and eliminate supplement and establishment fees).
Non-User Fee Policy Riders
As previously mentioned, FDARA includes a limited number of policy riders. There are two device-related policy riders. The first is the proposed establishment of a pilot accreditation scheme for conformity assessment to provide FDA the authority to audit and certify laboratories who conduct device conformance testing to a recognized standard, and also to withdraw the certification if necessary. The second is the proposed reauthorization third party review, with provisions to increase flexibility, such as through conducting a public guidance development process to identify the factors FDA will use to determine which devices are eligible for third party review.
In addition, FDARA would reauthorize a number of other programs for five years:

Pediatric humanitarian device exceptions;
Critical Path Public-Private Partnerships;
Pediatric Device Consortia; and
Orphan Drug Grants.

Finally, FDARA would reauthorize section 505(u) of the Federal Food, Drug, and Cosmetic Act, which provides FDA the authority to grant exclusivity for drugs containing single enantiomers for another 5 years. Perhaps this incentive will be used more in this reauthorization since it has only been used once to date (see our previous discussion of this exclusivity here).
The Future of FDARA
The question remains: will FDARA remain clean? There is still several months before the UFAs need to be reauthorized, so there is plenty of time for other policy priorities (e.g., drug pricing) to make their way into the bill – especially since it is considered “must pass” legislation. And it appears this option is not off the table with Energy & Commerce Committee Chairman Walden stating “as this process proceeds, I look forward to continued discussions with my colleagues in the House on other member priorities that could strengthen this important legislation.”

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So . . . About That Guilty Plea: The Government Responds to the Decosters’ Petition for Cert

So . . . About That Guilty Plea: The Government Responds to the Decosters’ Petition for Cert

By Jennifer M. Thomas –
We last updated readers on the Decosters’ criminal case in January, when the Decosters timely petitioned the Supreme Court for review of the Eighth Circuit decision upholding their three-month prison sentences under the FDC Act. Last week, the government responded to that petition.
As reported in our previous posts here, here, and here, the Decosters’ case is significant because it tests the limits of the Park doctrine, also known as the “responsible corporate officer” doctrine. The doctrine’s name originated with United States v. Park, 421 U.S. 658 (1975) (here), in which the Supreme Court held that the Federal Food, Drug, and Cosmetic Act (“FDC Act”), 21 U.S.C. § 331, imposes criminal liability on individuals whose corporate position affords them “the power to prevent or correct” violations of that section, even absent “knowledge of, or personal participation in” the violations. Park, 421 U.S. at 670, 676. Park expanded on an earlier Supreme Court decision upholding strict liability for a responsible corporate officer under a different statute in United States v. Dotterweich, 320 U.S. 277 (1943) (here).
By way of brief background, Jack and Peter Decoster, the former owner and CEO, respectively, of Quality Egg, LLC, were each sentenced to three-months imprisonment after pleading guilty to responsible corporate officer violations of the FDC Act. The government acknowledged that it lacked evidence of either Decoster’s knowledge of or participation in the FDC Act violations at issue. However, the U.S. District Court for the Northern District of Iowa found by a preponderance of the evidence at sentencing that the Decosters had acted negligently. The Eighth Circuit, in a split decision, upheld the Decosters’ three-month prison sentences. While the Eight Circuit panel was unanimous that a sentence of imprisonment for a “vicarious liability” offense – absent a finding of some blameworthiness or negligence – would not be permissible, two members of the three-judge panel determined that blameworthiness was either inherent in a responsible corporate officer conviction (Murphy, J.), or had been established in the Decosters’ case by the District Court at sentencing (Gruender, J., concurring).
The government’s brief in opposition to Supreme Court review of the Decosters’ sentences largely reflects Eight Circuit Judge Murphy’s, and in the alternative Judge Gruender’s, views of the law, and argues that the Decosters’ case is not an appropriate vehicle for the Supreme Court to resolve the questions of law raised in their petition.
The government points to the Decosters’ (1) “unqualified” guilty pleas to FDC Act misdemeanor offenses, and (2) agreement to be sentenced based on facts by the district court judge based on a preponderance of the evidence, as dispositive of the issues surrounding their sentencing. The government argues that the Decosters’ three-month prison sentences would have been justified based on the blameworthiness inherent in a responsible corporate officer conviction under the FDC Act, regardless of any fact-finding by the District Court. But the Decosters’ prison sentences were not based purely on their guilty pleas for responsible corporate officer violations of the FDC Act, and the District Court did find additional facts about the Decosters’ acts and omissions relating to the FDC Act violations at issue. The government emphasizes that in their guilty pleas, the Decosters agreed to be sentenced based on facts determined by the District Court judge by a preponderance of the evidence.
Finally, in response to the Decosters’ novel argument that the Park doctrine itself should be invalidated in its entirety, the government argues that their guilty pleas, and failure to contest the statutory basis for their convictions before the district and circuit courts, preclude Supreme Court consideration of that issue.
Despite the government’s opposition, the Decosters already have the support of multiple amici urging the Court to review their prison sentences. The Washington Legal Foundation and the National Association of Criminal Defense Lawyers both filed amicus briefs in support of the Decosters’ petition. If the Eighth Circuit briefing is any indication, additional influential amici may follow. Stay tuned – we will keep you posted on the Court’s disposition of the Decosters’ petition.

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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.

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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.

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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.

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