American Bakers Association Petitions FDA to Revoke or Revise the New Dietary Fiber Definition

American Bakers Association Petitions FDA to Revoke or Revise the New Dietary Fiber Definition

By Riëtte van Laack – 
On April 10, 2017, the American Bakers Association (ABA) submitted a Citizen Petition and a Petition for Stay of Action on FDA’s new definition of dietary fiber in 21 C.F.R. § 101.9(c)(6)(i), and the accompanying recordkeeping requirement in 21 C.F.R. § 101.9(g)(10) and (11).  
By way of background, FDA’s final rule issued in May 2016 defined dietary fiber as: 

non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic nondigestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health. 

FDA identified “[beta]-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A)), psyllium husk (as described in § 101.81(c)(2)(ii)(A)(6))[sic], cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose” as isolated or synthetic non-digestible carbohydrate(s) that have physiological effects that are beneficial to human health. Therefore, these non-digestible carbohydrates qualified as dietary fiber. The Agency indicated that it did not have sufficient evidence for a beneficial physiological effect for a number of other non-digestible carbohydrates. The Agency set a compliance date of July 26, 2018 for companies with more than $10 million in annual sales.   
In the months following the issuance of the final regulation, a number of companies submitted Citizen Petitions to amend the dietary fiber definition to include additional non-digestible carbohydrates. See, e.g., Docket No. FDA-2016-P-3620; Docket No. FDA-2016-P-1674; and Docket No. FDA-2016-P-2736.  In addition, General Mills submitted a Citizen Petition requesting that FDA extend the compliance date to allow for the required rule making and label revisions (or reformulation of products) for products containing dietary fiber.
It was not until November 2016 that FDA issued a Draft Guidance on the type and amount of scientific evidence fiber petitions would need to include before FDA would review whether an “isolated or synthetic” fiber met the definition of dietary fiber. The Agency also published a summary of the scientific and clinical data for non-digestible carbohydrates for which FDA had not been able to reach a conclusion in the final regulation. After an extension, the comment period for these two documents closed on February 13, 2017.
Since then, FDA has issued several interim responses to the Citizen Petitions advising Petitioners that it has “not been able to reach a decision on [the] petition[s] because of other agency priorities and the limited availability of resources.” These responses have raised serious concerns and uncertainty about the path forward given the imminent compliance date and the time needed to finalize the guidance, review the Citizen Petitions, and complete the notice and comment rulemaking required to amend the definition of dietary fiber. It thus comes as no surprise that the agency has been formally asked to hit the brakes.
The ABA Citizen Petition asks that FDA revoke the new definition of dietary fiber and reinstate the previous “chemical definition.” In the alternative, if FDA does not revoke the definition, ABA asks that FDA revise (and correct) the definition. In any case, while considering such revisions, ABA asks that FDA immediately stay the new definition.
The 29-page Petition posits a number of grounds as to why FDA should take the requested action including 1) FDA’s lack of authority to establish a physiological-based definition for dietary fiber (or any other nutrient); 2) the unjustified application of a different standard for intrinsic and intact fiber (which is presumed to have a beneficial physiological effect) vs isolated or synthetic fiber; 3) FDA’s failure to clearly define dietary fiber which violates the Administrative Procedure Act; and 4) the various errors in the definition of new dietary fiber (e.g., psyllium husk is not an isolated or synthetic fiber). In addition, in a 17-page Appendix to the Petition, Petitioners provide a detailed analysis of FDA’s limited authority to access and inspect records of food manufacturers, and argue that FDA does not have legal authority to establish the records access requirement for dietary fiber.
The Petition is limited to dietary fiber definition but some of the arguments, such as the issue of FDA’s (lack of) authority to access records, would appear to apply also to other aspects of the amended regulation (e.g., labeling of added sugars).
Meanwhile, some in the industry have sought to delay the compliance date of the rule to coincide with the compliance date of the yet to be developed regulations for GMO labeling.  Also, FDA’s draft guidance “Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals” appears to have raised additional questions concerning other aspects of the new regulation (see here).
All in all, it appears that there is great uncertainty within the industry as to how to comply with the new regulations and a need for more time. Additional actions seem likely.

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Apotex Petitons FDA on Biosimilar NEULASTA; Wants Comparative Clinical Efficacy Studies in at Least One Patient Population

Apotex Petitons FDA on Biosimilar NEULASTA; Wants Comparative Clinical Efficacy Studies in at Least One Patient Population

By Sara W. Koblitz –
Apotex and its subsidiary Apobiologix submitted a Citizen Petition (Docket No. FDA-2017-P-2528) on April 21, 2017 asking that FDA ensure a level playing field for all biosimilar applicants referencing NEULASTA (pegfilgrastim). A common tactic in the small molecule world to introduce additional hurdles to generic approval in an effort to extend market exclusivity, it isn’t typical to see this type of petition from a party who isn’t the brand or innovator.  But, as we have seen recently, the BPCIA is setting up some interesting competition schemes in an effort to reduce costs for consumers. As we discussed, whether increased competition between biosimilars will actually reduce costs for consumers in any meaningful way still remains to be seen, but it’s probably a positive indication for pricing that biosimilar manufacturers are trying to keep each other from the market.
Apotex submitted a 351(k) application to FDA for NEUPOGEN and NEULASTA, likely in December 2014. Apotex noted that it was required to perform its comparative studies in intended patient populations.  But, Apotex explained, Coherus issued a press release in October 2016 indicating that it had filed a 351(k) application for NEULASTA, but only evaluated the clinical effect in healthy subjects. 
In this petition, Apotex asks FDA to require all biosimilar applicants referencing NEULASTA to conduct comparative clinical efficacy studies in at least one intended patient population. Apotex argues that comparative studies in healthy patients alone would not demonstrate that there are “no clinically meaningful differences” between a proposed biosimilar and NEULASTA for one of the indications of NEUALSTA, a decreased incidence of infection.  The argument was based on the notion that every approved biosimilar thus far has conducted trials in at least one indicated patient population.  The question at issue here is ostensibly what FDA really means by the term “no clinically meaningful differences.”  But the real issue Apotex wants to address here is consistency of approval standards across biosimilar manufacturers.
Additionally, Apotex requested that FDA require biosimilar applicants referencing NEULASTA to conduct immunogenicity studies over at least four cycles. Apotex makes an interesting point that if FDA required sponsors to conduct more rigorous comparative clinical efficacy patients in cancer chemotherapy patients, oncologists are more likely to consider using a biosimilar than the reference product.  If that is in fact true, then it might behoove biosimilar manufacturers to perform this type of study for marketing purposes alone.            

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Court Applies First Amendment Protections to FDA-Related Claims

Court Applies First Amendment Protections to FDA-Related Claims

By Anne K. Walsh –
Although the First Amendment has been more often discussed in the context of drug and medical device promotion, the Eleventh Circuit recently evaluated whether claims for a food also deserve similar constitutional scrutiny. In Ocheesee Creamery LLC v. Putnam, the Eleventh Circuit considered whether the State of Florida’s actions prohibiting the truthful use of the term “skim milk” violated the First Amendment, and held that the state’s restriction of the creamery’s description of the product as “skim milk” violated the Central Hudson test for commercial speech regulation.
The Ocheesee Creamery is a seller of skim milk, which, consistent with standard practice, is produced by skimming the cream from the top of the milk. The leftover product is skim milk. Although the skimming process depletes the vitamin A from the milk, the creamery does not replace the lost vitamin A because it sells only all-natural, additive-free products.
The issue arose because Florida law prohibits the sale of “milk” that does not contain vitamin A. During attempts to compromise, the state proposed that the creamery could include a label that used the term “milk product” in place of “skim milk.” The creamery ultimately brought suit in the U.S. District Court for the Northern District of Florida, arguing that the state’s refusal to allow it to call its product “skim milk” amounted to censorship in violation of the First Amendment. The court rejected the creamery’s claim, and granted summary judgment to the state.
On appeal, the Eleventh Circuit disagreed. Its opinion walks through the Central Hudson analysis for evaluating commercial speech. The threshold question asks whether the expression is protected by the First Amendment at all. Commercial speech does not merit First Amendment protection if (1) the speech concerns unlawful activity, or (2) the speech is false or inherently misleading. The court found that the speech did not violate the first prong, relating to unlawful activity, because the state does not ban the sale of milk without vitamin A. Instead vitamin-deficient skim milk can lawfully be sold as “imitation” milk. Thus, the court held that the state’s action is a speech regulation because the court would permit the sale but for the speech: calling it “skim milk.”
The court evaluated the second prong, whether the speech is false or inherently misleading. The state relied on its definition of “skim milk,” which the creamery’s product did not meet because it did not contain vitamin A, and argued that it was false or inherently misleading to consumers to label a product inconsistent with this definition. Curiously, nowhere in the court’s opinion does it reference FDA’s regulation of skim milk at 21 C.F.R. Part 131, which does not contain a similar vitamin A requirement.   The court rejected the state’s premise that any use of a defined term inconsistent with the state’s preferred definition is inherently misleading. “Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.” Instead, the court reviewed the Webster’s dictionary definition of “skim milk,” and concluded that consumers did not expect skim milk to meet the state’s “alternative definition.”
Thus, the court concluded that the state did not meet its burden to satisfy Central Hudson, and vacated the summary judgment prohibiting the creamery’s use of the term “skim milk.” The case was remanded to the district court for further consideration.

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FDA Licences Renflexis; Some Firsts for this Remicade Biosimilar

FDA Licences Renflexis; Some Firsts for this Remicade Biosimilar

By Sara W. Koblitz –
On April 21, FDA approved Samsung Bioepis’ Renflexis, a biosimilar referencing Pfizer’s Remicade. Like Remicade, Renflexis is approved for the treatment of Crohn’s Disease (both pediatric and adult), Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis.  Remicade was approved as an Orphan Drug in 1998 and faced no competition until April 2016. In April 2016, FDA approved Inflectra, another biosimilar product referencing Remicade.
The approval of Renflexis marks just the fifth biosimilar to have received approval since the implementation of the BPCIA in 2005.  It also marks the first time that FDA has approved a biosimilar referencing a product that already has a biosimilar (and without an advisory committee meeting), introducing more competition into the Remicade market and an element of competition between biosimilars themselves. While it is obviously too early to see a competitive effect of this approval, it should, in theory, have a positive impact on biologic prices for consumers.
However, at this point, the effect of the BPCIA on biologic prices has been less than hoped.  Zarxio, referencing Neuopogen, was only 15% lower in price than Neuopogen after six months on the marketing and only captured about 10% of Neupogen’s market share. Similarly, Inflectra has captured about the same from Remicade thus far. In a typical small molecule product, generics are approximately 40% of the cost of the reference product and capture about 75% of sales. Granted, generics are, by definition, interchangeable with their reference products while biosimilars require extra approval to be considered interchangeable. But from an economic standpoint, the more biosimilars approved for a product, the more prices should fall. However, how accurate this prediction will be in the biosimilar context is an open question given that biosimilars are not interchangeable with their reference products. (No product has yet been approved as interchangeable under the BPCIA.)
Without mandatory substitution, biosimilars will only capture more market share if health care professionals make the conscious decision to switch from a reference product to a biosimilar.  And this will require their review of labeling and literature to determine if a biosimilar is appropriately substitutable for its reference product. With multiple options in the same category, this will make more work for already hurried health care professionals. There is also a question of whether Renflexis will contribute to a larger erosion of the Remicade market share or whether it will only eat away at the market share of Inflectra. And, given the naming conventions adopted for biosimilars, each biosimilar will need to build brand awareness of its own product: because each biosimilar has a distinct name, the marketing required by biosimilar companies could eat into potential savings for consumers.
In time, we may see more state rules relating to substitution in an effort to increase the competitive effect of biosimilars, but there is no telling how states will handle the issue of interchangeability.  While more competition is definitely a step in the right direction for biologic pricing, it remains to be seen whether non-interchangeable biosimilars will actually have an impact on the biologic market and its prices.

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Forum Shopping for Agency Deliberative Documents? San Francisco is the Place to Be (For Now)

Forum Shopping for Agency Deliberative Documents? San Francisco is the Place to Be (For Now)

By Jay W. Cormier & Anne K. Walsh –
It has been 40 years since Steve Perry changed the lyrics to the iconic song Lights to refer to San Francisco rather than Los Angeles.  As it turns out, litigants looking to gain easy access to otherwise confidential agency documents may want to make the same choice.
As we have detailed before (here), in March of last year, several organizations sued FDA and the U.S. Fish and Wildlife Service to challenge FDA’s November 2015 approval of the genetically engineered AquAdvantage Salmon (a full description of the salmon can be found in our earlier post on that topic, here).  After 12 months of litigation, the case has not proceeded past discovery.  FDA has thus far produced over 38,000 pages of documents to the plaintiffs. 
Much to the plaintiffs’ chagrin, those documents do not include internal deliberative documents that detail FDA’s thinking during the more than 20 years that FDA reviewed the salmon before approval. The plaintiffs demanded that FDA provide them these internal deliberative documents, and the U.S. District Court for the Northern District of California agreed, issuing an order requiring FDA to supplement the administrative record with hundreds of thousands of additional documents.
On April 19, 2017, FDA took the unusual step of filing a petition with the U.S. Court of Appeals for the 9th Circuit asking that the court issue a writ of mandamus (a fancy phrase for an order to a lower court when the lower court has acted contrary to law) requiring the lower court to vacate its ruling. 
As arcane as this case may initially sound, the breadth of its implications is difficult to understate.
Federal agencies, including FDA, make administrative decisions on a daily basis, whether that is issuing a permit, denying a petition, or granting approval for a product. Prior to making these decisions, these agencies gather data and information and may even seek public comment.  Importantly, agencies deliberate internally and (often) with other governmental agencies.  There is no doubt that the contents of public comments to an agency as well as the specific data used to support an agency decision are a part of the administrative record of the decision.  The question posed in the AquAdvantage Salmon litigation is whether the written documents that constitute the agency deliberative process are also a part of that administrative record.
This is a critical question because the public should be entitled to review the administrative documents that constitute the administrative record for a given agency decision. Congress, when passing the Administrative Procedure Act, stated that the “exclusive record for decision” consists of the “transcript of testimony and exhibits, together with all papers and requests filed in the proceeding.”  5 U.S.C. § 556(e).  
In 1938, however, the U.S. Supreme Court stated that it is “not the function of the court to probe the mental processes” of a government agency. U.S. v. Morgan, 304 U.S. 1, 18 (1938) (here).  Many courts, including the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. District Courts for the Eastern and Central Districts of California, have determined that, following U.S. Supreme Court precedent, the internal deliberations of federal agencies are not subject to review.  This is not to say that such internal deliberations are free from public scrutiny, but rather it reflects the policy choice that, absent a strong showing that the government acted in bad faith, the public is best served by allowing agencies to freely debate administrative decisions without the chilling effect of having all deliberative documents subject to public disclosure and review. 
Interestingly, however, the Northern District of California has a history of granting plaintiffs access to agency deliberative documents. Over the last 15 years, this district court has allowed access to deliberative documents from the Department of Justice, the Environmental Protection Agency, and the U.S. Department of Agriculture, to name a few.  FDA’s position in its filing is that the court erred when it required  FDA to provide plaintiffs documents that detail FDA’s deliberative process, and that the district court’s decision is at odds with the precedent established by the Supreme Court, other circuit courts, and  the Administrative Procedure Act. 
FDA goes further to note that compliance with the lower court’s order to produce the deliberative documents would be overly burdensome. After a negotiated narrow search of just three document custodians, FDA identified approximately 400,000 pages of responsive material.  If the FDA staff dedicated to reviewing those documents prior to production were to work on the ordered production only, FDA asserts that it would take the agency over three years to review just those documents.  Of note, the plaintiffs are currently seeking documents from 17 custodians and have reserved the right to seek additional documents in the future.  At that rate it will take over a decade for FDA to fully respond to the document request from the plaintiffs.  Unlike private party defendants, who the Department of Justice expects to review similarly large productions in a matter of months, FDA asserts it has no available resources to hire additional staff to speed the document review process.  After years of sequester and budget cuts, it is difficult to imagine Congress or the President providing additional appropriations to facilitate document production in this case.
According to FDA, if the court denies FDA’s petition, the entire government will be exposed to innumerable lawsuits seeking production of deliberative documents. Further, subsequent internal deliberations may be stymied given they will be conducted with knowledge that expressed opinions and open debate will potentially be subject to public scrutiny, even if the ultimate agency decision is substantially different from those opinions and debate. 
At bottom, because the 9th Circuit has not ruled previously on this specific question of law, it will be interesting to see whether the court is ready to open its circuit to all comers dreaming of pulling back the curtain of the government’s deliberative process or whether the court will follow the rulings of other courts.  We will continue to monitor this case and this important petition. 
The court may deny the petition without an answer from the respondent or may order the respondent to file an answer within a fixed period of time.

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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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