FDA and FTC Announce New Steps Under the Biosimilars Action Plan, Which Include Targeting False and Misleading Statements About Biosimilars

FDA and FTC Announce New Steps Under the Biosimilars Action Plan, Which Include Targeting False and Misleading Statements About Biosimilars

By Suchira Ghosh

On February 3rd, FDA announced several new actions as part of its Biosimilars Action Plan (BAP).  If you recall, back in July 2018 when FDA first unveiled the BAP, four key elements were identified:  improving efficiency of biosimilar and interchangeable product development; maximizing scientific and regulatory clarity for biosimilar development; developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and supporting market competition by reducing gamesmanship or other attempts at unfairly delaying competition.  Each of these elements was associated with a number of priority deliverables, and, since then, FDA has been taking steps to meet those (for example, see our prior discussions here and here).

FDA’s most recent actions seek to address the biosimilar market competition element of the BAP.  First, FDA and FTC issued a lengthy joint statement that identified four goals to help combat anti-competitive practices in relation to biosimilars:  (1) coordinate to promote greater competition in biosimilar markets; (2) work together to deter behavior that impedes access to samples of the reference biological product that are required for testing and development of follow-on products; (3) take actions against false or misleading communications about biologics, including biosimilars; and (4) review patent settlements involving biologics, including biosimilars, for antitrust violations.  In particular, the agencies noted their concern with false or misleading statements comparing biological reference products and biosimilars, which may be hampering uptake of biosimilar therapies by creating negative misperceptions about the safety and efficacy of biosimilars.  The agencies “intend to take appropriate steps to address companies” who are engaged In such practices.

To further clarify how data and information about biosimilars should be presented in a truthful and non-misleading manner in regulated promotional materials, FDA announced the release of the Draft Guidance for Industry: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers and invited comment by stakeholders in the docket.  The draft guidance addresses various considerations, such as identifying reference products and biosimilars in promotional materials, presenting studies that were conducted in support of reference product approval in biosimilar promotional materials, presenting data in promotional material derived from biosimilarity studies that are not part of the biosimilar labeling, and presenting  comparisons/comparative claims between reference products and their biosimilar, to name a few.

As part of their efforts to promote greater competition, FDA and FTC also announced that they would be holding a public workshop on March 9 at White Oak, with the goal of bringing together stakeholders from the government, industry, and academia to “discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.”  The agencies are inviting written comments and in-person presentations.

And, unlike FTC’s November 2017 workshop on competition in prescription drug markets where FDA was a presenter, the upcoming biologics competition workshop is clearly an effort undertaken by the agencies in collaboration.  While FDA and FTC have not always seen eye to eye on all emerging biosimilar issues (such as naming conventions), the statement and workshop make clear their agreement that there will be increasing amounts of promotional activity relative to biosimilars, that such promotional activity could have a chilling affect on the uptake of biosimilars unless it is done in a truthful and non-misleading manner, and that they may be willing to take action sooner rather than later.

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FDA’s Getting Its Priorities Straight: Revised ANDA Priority MAPP

FDA’s Getting Its Priorities Straight: Revised ANDA Priority MAPP

By Sara W. Koblitz

Only about 2 years after its last revision (which was only 5 months after its previous revision), FDA decided this week that MAPP 5240.3, Prioritization of Original ANDAs, Amendments, and Supplements, just wasn’t working.  With too many ANDA submissions designated as priority, and thereby entitled to 8 month review, FDA released version 5 of MAPP 5240.3 to try to more efficiently allocate its resources “to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants.”   As Dr. Choe shared in her statement announcing the revised MAPP:

Under the previous prioritization policy, roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of blocking patents or exclusivities.

This practice strained the agency’s limited resources and did not support the agency’s goal of ensuring that ANDAs for those drugs with the greatest potential impact on public health are prioritized.

It seems that, despite FDA’s best efforts, the June and November 2017 versions created much more work for the Agency than anticipated.  For that reason, FDA has reconfigured its “prioritization factors and procedures.”

While the prioritization factors, generally speaking, have remained largely the same, the approach to granting Priority Review and prioritizing applications containing Paragraph IV certifications has changed a bit.  Firstly—and importantly—FDA will no longer prioritize review of an ANDA unless there is “an explicit request from the applicant at the time of submission” that includes the prioritization factors under which the applicant qualifies for priority review.  The only products that FDA will consider for priority review without such a request are products on FDA’s Drug Shortage list and products for which there are not more than 3 approved drug products in the Orange Book and for which there are no blocking patents or exclusivities listed for the RLD.  Any other type of drug product needs to explicitly state “Priority Review Requested,” include the basis for the request, and provide sufficient supporting documentation for the request.  Priority review applies to the entire application—not just an indication or strength that meets the priority review criteria.

Further, while FDA may still grant priority review after an ANDA has been submitted and received, it will not adjust a goal date for a submission even if the product later becomes eligible for priority review. If, for example, an already-submitted ANDA wouldn’t otherwise qualify for priority review but becomes subject to a drug shortage under section 506E of the FDCA at some time during the review process, FDA may still grant priority review, but it will not change the GDUFA goal date to reflect that priority status.  This means that once an ANDA receives a goal date, priority review basically just becomes expedited review, in which FDA will try to act on the ANDA as soon as possible but makes no actual commitment.

With respect to prioritization itself, FDA ditched the numerically-ranked Prioritization of Review in favor of “Prioritization Factors” that don’t appear to have a hierarchy.  The same categories as version 4 are still subject to priority review:

  • Submissions with inadequate generic competition and no blocking patents or expired exclusivities listed in the Orange Book;
  • Submissions with paragraph IV certifications and exclusivity considerations;
  • Submissions related to drug shortages;
  • Submissions subject to special review programs (like the President’s Emergency Plan for AIDS Relief);
  • Submissions related to public health emergencies;
  • Submissions related to certain government purchasing programs (like the Government-Wide Quality Assurance Program);
  • Submissions subject to statutory mandates or other legal requirements;
  • Supplements for public health reasons or supplements in which a delay would impose extraordinary hardship on the applicant (essentially resulting from catastrophic events); and
  • Sole source products.

Only the considerations for Paragraph IV filers and ANDAs blocked by exclusivity appear to have actually changed.

Previously, FDA prioritized ANDAs containing paragraph IV certifications even if the ANDA would be blocked from marketing for years due to patents, 30-month stays, or exclusivity.  The revised ANDA limits priority review only to submissions ‘that will be ready for final approval at or before the goal date for that submission” and are from first-filers, from applicants blocked by a first-filer whose 180-day exclusivity has been triggered, or seek approval of a drug with limited competition (fewer than four therapeutically equivalent drug products listed in the Orange Book at the time of submission).  When approval for a noncomplex generic with limited competition is dependent on expiration of a patent or NDA exclusivity, the application will receive priority review if submitted between 24 and 36 months prior to expiration of the last applicable patent or exclusivity period; for complex products, priority is given to these applications submitted between 36 and 48 months prior to expiration of the last-expiring patent or exclusivity.

Importantly, FDA is now requiring documentation that the application will be eligible for final approval at or before the goal date for that submission.  For some of these factors, like a drug shortage, submitting this documentation is theoretically easy.  Or if you have tentative approval but are blocked by a first-filer’s 180-day exclusivity, documentation that the 180-day exclusivity period has started to run can be submitted without much challenge.  But for others—particularly paragraph IV filers—it presents a procedural challenge to get a priority review goal date.  Paragraph IV filers must wait to provide notice to the RLD sponsor until FDA receives its ANDA.  Once the ANDA filer provides its notice, the RLD sponsor has 45 days to sue the ANDA sponsor.  If the RLD sponsor doesn’t sue, then it will be easy to provide documentation that the product will be eligible for approval at goal date, but that can’t happen until at least 100 days after ANDA submission (60 days for FDA to “receive” the ANDA and 45 days to wait to see if the RLD holder will sue).  But FDA won’t assign a priority review goal date without that documentation.  So, presumably, FDA will have already assigned a non-priority review date to that ANDA upon receipt.  And even though it now meets the criteria for priority review, FDA won’t amend an already-assigned goal date and will only promise its best efforts to review quickly (expedited review).  And what about ANDAs for products with limited competition but will be blocked by  unapproved first-filers.  How do those applicants show  that they’ll be ready for approval at goal date?  Especially when FDA won’t make a determination about 180-day exclusivity forfeiture until another ANDA applicant is ready for approval.  And if you’re a first-filer subject to a 30-month stay, the revised MAPP means that you cannot get a priority review goal date because you won’t’ become eligible for priority review until the relevant litigation has been settled, dismissed, or completed.  For some, especially those going through an entire trial, it may not matter, but for those who settle quickly, ineligibility for a priority review date could delay market entry because the ANDA sponsor couldn’t provide documentation of a settlement before litigation even commenced.

Additionally, even though it’s implicit that the documentation FDA now requires to demonstrate that an application will be ready for final approval at the goal date is specific to applications subject to blocking patents or exclusivities, the MAPP could be interpreted to require documentation that the ANDA itself is robust enough for approval at the goal date.  If FDA decides for some reason that such documentation is needed, priority review assignment could become very subjective.  And even if FDA does not apply the policy this way, it is policy that FDA will not accelerate a goal date once an initial date is granted means that a lot of applicants are only entitled to vague promises of expedited review even if the ANDA meets the requirements for priority review.  Obviously, FDA is still working out some kinks in its priority review process.  Hopefully, the fifth time is the charm, but it remains to be seen how well this new documentation requirement will be enforced.

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ACI’s 35th FDA Boot Camp – New York Edition

ACI’s 35th FDA Boot Camp – New York Edition

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY.  The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

ACI’s FDA Boot Camp will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also key sessions that show you how this regulatory knowledge can be applied to situations you encounter in real life. A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including:

  • The organization, jurisdiction, functions, and operations of FDA
  • The essentials of the approval process for drugs and biologics, including: INDs, NDAs, BLAs, OTC Approval, the PMA process and the Expedited Approval Process
  • Clinical trials for drugs and biologics
  • Unique Considerations in the approval of combination products, companion diagnostics, and stem cell therapies
  • The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics
  • Labeling in the drug and biologics approval process
  • cGMPs, adverse events monitoring, risk management and recalls

In addition—and new for 2020—are special focus sessions on:

  • FDA’s Digital Health Initiatives
  • Opioid and Other Controlled Substances Classifications

Hyman, Phelps & McNamara, P.C.’s Suchira Ghosh will lead a workshop titled “Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-874-874DX01.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.

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CSPI Letter Asking that FDA Act Against Misleading and Unauthorized Sugar Claims Is Followed by Class Action Complaint

CSPI Letter Asking that FDA Act Against Misleading and Unauthorized Sugar Claims Is Followed by Class Action Complaint

By Riëtte van Laack

In a letter dated January 9, 2020, the Center for Science in the Public Interest (CSPI) asked FDA to take immediate enforcement action to prevent what CSPI argues are misleading and unauthorized implied “low sugar” and “reduced sugar” claims, such as “lightly sweetened” and “less sweet,” on beverage products that are “high” in sugar.  In addition, CSPI asked FDA to issue regulations regarding “added sugar” claims.

In the letter, CSPI argues that claims such as “slightly sweetened,” “sorta sweet,” and “just a tad sweet” are implied nutrient content claims that the food is “low sugar” rather than a reference to the taste of the product.  Similarly, CSPI argues that a claim “less sweet” is a reduced sugar claim.  Nutrient content claims are claims that expressly or implicitly characterize the level of a nutrient.   Such claims may be made only if they are authorized by law.  FDA has not defined or authorized the nutrient content claim “low sugar.”  Moreover, although FDA regulations allows a “reduced sugar” claim, such a claim may be made only if the product meets certain requirements and the label includes specific disclosures.  CSPI identifies 19 products from five different brands that allegedly are misbranded because they use unauthorized implied low sugar or reduced sugar claims.  CSPI argues that the claims are not only violative but are “also particularly misleading” because the products contain 22-36% of the daily value for added sugars per Reference Amount Customarily Consumed.

In addition to requesting that FDA take enforcement action against companies marketing beverages with allegedly misleading unauthorized implied “low sugar” and “reduced sugar” claims, CSPI “encourages” the Agency to expeditiously issue regulations authorizing a “low added sugar” nutrient content claim.  As readers of this blog know, the updated nutrition labeling regulation requires the declaration of added sugars in addition to total sugars.  The updated regulation also established a daily value for added sugars (not for total sugars).  As a result, it would now be possible to define “low added sugars” similar to other “low” nutrient content claims.

It remains to be seen whether CSPI’s letter prompts a response from FDA.  In the interim, CSPI’s arguments could gain traction with the plaintiff’s bar.  In fact, on January 23, 2020, a complaint was filed against the Coca-Cola company in which plaintiffs allege that they were misled into believing that Honest tea beverages (among the products highlighted in the CSPI letter) labeled as “Just a Tad Sweet” were low in sugar and calories.  The action was filed in in New York federal court under various state laws for consumer protection, misrepresentation, breach of express and implied warranty, fraud, and unjust enrichment.

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California Dreaming Part 2: The Constitutional Challenge

California Dreaming Part 2: The Constitutional Challenge

By Sara W. Koblitz

Back in September 2019, California passed AB 824: Preserving Access to Affordable Drugs.  That law sought to discourage “reverse-payment agreements” in which a brand manufacturer enters into a patent settlement agreement with a potential generic sponsor that involves a transfer of value from the brand to the generic without authorizing immediate generic market entry.  As we explained in our last post, AB 824 does not ban these types of agreement per se, but instead presumes that such agreements are anticompetitive where the ANDA sponsor receives “anything of value” from the brand manufacturer as part of a Paragraph IV litigation settlement.  As a result, AB 824 effectively shifts the government’s usual burden of proving anticompetitive effect to the drug sponsors, who now must show that a given settlement is not anticompetitive.  This shift is significant: It not only requires pharmaceutical companies to prove a negative, but will require the affected parties to disclose substantial proprietary information about these settlements to the California Attorney General.  At the time AB 824 was passed, we asked whether AB 824 would actually have any effect on these types of settlements (or whether California was merely dreaming).   And given the considerable impact AB 824 likely would have on the pharmaceutical industry, we also suggested that AB 824 likely would be subject to a constitutional challenge from industry.

Industry did not disappoint.  In November 2019, the Association for Accessible Medicines (“AAM”) sued the California Attorney General and sought both preliminary and permanent injunctions staying the implementation of AB 824 on January 1, 2020.  AAM is no stranger to this type of litigation: it successfully sued the Maryland Attorney General’s Office back in 2017 over a Maryland law addressing generic drug pricing.  Like its suit against Maryland, AAM’s challenge to AB 824 alleges that AB 824 violates the dormant Commerce Clause because it extends far beyond California entities and agreements.  Further, AAM alleged that federal law preempts AB 824—specifically alleging that the state law is inconsistent with the federal patent laws, federal antitrust law as set forth in FTC v. Actavis, and the delicate balance between innovation and competition that Congress established in the Hatch-Waxman Amendments and Biologic Price Competition and Innovation Act.  AAM also argued that AB 824’s imposition of a minimum penalty of $20 million violates the Excessive Fines Clause in the Eighth Amendment of the U.S. Constitution.  Finally, AAM maintained that AB 824 contravenes the basic notions of procedural due process because the presumption that any settlement is anticompetitive provides no meaningful opportunity for rebuttal.

On December 31, 2019, the U.S. District Court for the Eastern District of California denied AAM’s request for preliminary injunctive relief “due to the nature of Plaintiff’s pre-enforcement attack on AB 824.”  But despite this headline “loss” for the industry challengers, the district court all but agreed with AAM’s central constitutional challenge by making clear that the enforcement of AB 824 to settlements executed outside of California and between non-California entities almost would certainly be unconstitutional:

if the [California] Attorney General were to enforce the terms of AB 824 against two out of state parties that entered into a settlement agreement outside of California, having nothing to do with California, such conduct would likely violate the Dormant Commerce Clause.

Nevertheless, the Court explained, “invaliding or even preliminarily enjoining the law on this basis would force the Court to not only assume the Attorney General will apply the law unconstitutionally, but also make a constitutional determination before it is necessary to do so.” The Court refused to presume that California would apply AB 824 in such clearly unconstitutional fashion, and therefore found that AAM could not establish the elements necessary for an as-applied pre-enforcement challenge—namely, the existence of a concrete plan to violate AB 824, a communicated threat of prosecution under AB 824, and/or a history of past prosecution or enforcement of AB 824.  In short, while the Court effectively held that AAM likely would prevail if California applied AB 824 to the vast majority of patent settlements (which are executed outside of California, by companies domiciled outside of California), the Court simply found it premature to enjoin the statute given uncertainty about whether the State would attempt to apply the statute in such an unconstitutional fashion.

The Court also opined on AAM’s likelihood of success under the three other cited causes of action: field preemption, the Excessive Fines Clause, and procedural due process.  Because AB 824 does not address the validity of patent law, the Court determined that federal patent law does not preempt AB 824.  The Court also explained that because Actavis permits enforcement of antitrust law on patent settlements rather than foreclosing enforcement, federal antitrust law does not preempt state antitrust law.  And because the effect of AB 824 on generic drug applications cannot be discerned until AB 824 has been implemented, the Court determined that it was impossible to know whether AB 824 actually conflicts with the Hatch-Waxman Amendments, stating:

Because AB 824 has not been enacted, nor has any other similar law been enacted in another state, it is impossible to know if this law will have its intended effect, or as Plaintiff argues, will backfire, causing generic drug companies to cease filing ANDA applications and challenging patents held by brand-name drug companies. The Court is not in a position to predict the future impacts of AB 824 before it is enacted and enforced. At this time, it is too speculative for the Court to find one way or another that AB 824 will frustrate or further the aims of the Hatch-Waxman Act.

The Court further determined that AAM’s Excessive Fine Clause and procedural due process counts suffered from the same speculation issue.  Noting that the imposition of $20 million penalties (or three times the value at issue in the settlement agreement) could be appropriate in certain circumstances, the Court determined that AAM’s facial attack on the penalty failed.  And because an as-applied analysis requires a balance of the penalty against the infraction, the as-applied pre-enforcement challenge on the penalty provision was too fact-specific to address in the abstract.  Similarly, the procedural due process challenge was also premature because AB 824 provides a mechanism by which a party can rebut the anticompetitive presumption of a Paragraph IV settlement, which the Court cannot assess for meaningfulness until it has been employed.

The Court briefly addressed the other elements necessary for an injunction—irreparable harm, public interest, and balance of harms.  With respect to irreparable harm, the Court stated that AAM failed to establish that irreparable harm is both likely and imminent.  Further, the Court explained that “the question of balance of harms and public interest are too speculative at this point for the Court to find that either factor favors Plaintiff, sharply or otherwise.”

While this decision is a procedural setback for AAM, who has already submitted its Notice of Appeal, it is one that AAM has faced before.  In its Maryland challenge, the U.S. District Court for the District of Maryland dismissed AAM’s dormant Commerce Clause claim and denied AAM’s motion for injunctive relief (while allowing a vagueness claim to proceed).  AAM appealed, and the Fourth Circuit reversed the district court, holding that the Maryland provision was unconstitutional under the dormant Commerce Clause “because it directly regulates transactions that take place outside of Maryland.”  There’s no reason, therefore, for AAM to give up hope just yet.  As we noted, the District Court agreed that the same issue arises here.

Clearly, AAM has signaled its intent to fight here.  However, while the appeal is pending, AB 824 technically already has gone into effect.  So while we wait to see if how the Ninth Circuit reacts to the pre-enforcement challenge argument, we will also be waiting to see how California actually does enforce AB 824.  Given the Court’s strong warning about AB 824’s constitutionality in the mine run of cases, we suspect that any enforcement actions taken under AB 824 will be subject to further litigation.  But like we said back in September: we will have to wait to see whether AB 824 will survive pre-enforcement litigation, whether it will be considered constitutional when actually applied, and whether it will have any effect on pay-for-delay settlements—or whether California is only dreaming.

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HP&M’s Serra Schlanger to Present on State Drug Price Reporting Laws

HP&M’s Serra Schlanger to Present on State Drug Price Reporting Laws

Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020.  This conference gathers stakeholders to examine the evolving landscape of state drug price reporting and transparency efforts.  Serra will speak about the state laws that require price disclosures to be made directly to health care providers, as well as join a panel of experts to discuss recent developments and practical tips for compliance with the various state requirements.

As a sponsor of the event, we can offer our readers a special $500 discount off the registration.  The discount code is DPC500, which expires on February 7.  We look forward to seeing you at this conference.

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Offense May Not Be the Best Defense: Court Dismisses Lawsuit by Raw Pet Food Company Seeking to Invalidate CPG

Offense May Not Be the Best Defense: Court Dismisses Lawsuit by Raw Pet Food Company Seeking to Invalidate CPG

By Riëtte van Laack

Lystn, LLC (also doing business as Answers Pet Food; Lystn) is a pet food manufacturer of raw pet food.  Lystn has been in a battle with FDA and the Colorado Department of Agriculture (CDA) since 2018 when CDA collected a sample of Lystn’s Straight Beef Formula for Dogs that allegedly tested positive for Salmonella and Listeria monocytogenes.  On January 9, 2019, FDA issued a Public Warning Notice cautioning consumers about Lystn’s Straight Beef Formula for Dogs because, according to FDA, the product represented a serious threat to human and animal health due to the presence of Salmonella.

CDA pursued action against the Company in the Colorado Office of Administrative Courts based on the positive sample.  Lystn attributed CDA’s enforcement action to FDA, alleging that FDA “through the CDA, ha[d] chosen to prosecute [the Company] for alleged violations” of FDA’s compliance policy guide, Salmonella in Food for Animals (CPG).  This CPG states that “FDA considers a pet food to be adulterated under . . . 21 U.S.C. 342(a)(1) when it is contaminated with Salmonella and will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella” and identifies criteria for determining whether such pet food should be subject to seizure. The Association of American Feed Control Officials’ (AAFCO) model bill and regulations and the CDA definition of “adulteration” mirror, or are similar to, FDA’s definition of “adulteration” in the CPG.

In July 2019, Lystn sued FDA, AAFCO, the CDA, three CDA employees, and HHS, in the U.S. District Court for the District of Colorado seeking a declaratory judgment that Lystn had been denied its due process rights and an injunction against FDA and AAFCO from applying and enforcing the CPG against Lystn.  Specifically, Lystn sought to enjoin FDA and AAFCO from pursuing any pending enforcement action based on the CPG, preventing the reintroduction of similar CPGs, and expunging all claims and references related to Lystn’s distribution of an adulterated product related to the CPG.  Defendants moved to dismiss plaintiff’s action alleging lack of subject matter jurisdiction (Federal and State defendants) and personal jurisdiction (AAFCO).

The Court granted all motions to dismiss.  It dismissed the action against federal defendants because, according to the Court, the CPG does not constitute final agency action.  Instead, the CPG “simply provides information to staff members concerning the interpretation of 21 C.F.R. § 342(a)(1)” to determine if administrative actions are necessary; the CPG does not create a legal right, instead “FDA’s enforcement power stems from 21 U.S.C. § 334.”  The Court compared  FDA’s public warning to a warning letter, which, as the Court noted does not constitute final agency action either.

Plaintiff’s argument that CDA’s enforcement action was a “thinly-veiled enforcement attempt by . . . FDA” because FDA compels states regulatory agencies to enforce the CPG (a “shadow regulation”) in exchange for FDA funding, also failed because, according to the Court, Plaintiff did not provide evidence that CDA’s action was at the behest of FDA.  Moreover, even if it had done so, CDA’s acts of collecting samples and initiation of an investigation did not constitute final agency action.

The action against the State Defendants also was dismissed because the Administrative Procedure Act (APA) does not create a private cause of action against State Agencies.  Plaintiff claimed that the State agencies were a vehicle of FDA, but the Court determined that there was insufficient evidence of a connection between the State Agencies and FDA to create subject matter jurisdiction.  Thus, the State agencies could not be sued for a violation of the federal APA.

The Court dismissed the case with prejudice.  As suggested by the title, this action concerned a company suing FDA pre-enforcement, not a company defending against FDA’s final action.

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HP&M is Pleased to Welcome Gail Javitt to the Firm as a Director

HP&M is Pleased to Welcome Gail Javitt to the Firm as a Director

By Kurt R. Karst

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Gail Javitt has become its newest Director.   Many leading companies have turned to Gail for her deep knowledge, skills, experience and thought leadership on the complex regulatory issues they face while looking to innovate and comply with existing and emerging FDA regulations.

As a Director at HP&M, Gail will provide strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, human cellular and tissue-based products (HCT/Ps) throughout the product lifecycle. Gail has successfully resolved disputes for these types of entities both at the pre-and post-market stages. She also has significant experience advising clinical laboratories on FDA and Clinical Laboratory Improvement Amendments (CLIA) requirements for laboratory developed tests.

In addition, Gail has published and spoken widely on issues at the intersection of law, science, ethics and policy, including FDA regulation of clinical trials, genetic testing, precision medicine and next generation sequencing.  Early in her career, Gail worked at the Genetics and Public Policy Center (part of Johns Hopkins University), as a law and policy director.  In this role, she was responsible for developing policy options to guide the development and use of reproductive and other genetic technologies.

Gail’s academic experience has included serving as a faculty member at the Berman Institute of Bioethics at Johns Hopkins University and as an adjunct professor at the Georgetown University Law Center, American University’s Washington College of Law and the University of Maryland School of Law.  She earned her J.D., cum laude, from Harvard Law School; her Master’s in Public Health from Johns Hopkins University and her B.A., phi beta kappa, magna cum laude, from Columbia College.

“Joining a firm known specifically for its intentional focus on the FDA and the needs of the health care and life sciences industry is important to me because of the exceptional resources that they can offer its clients. Combining my experience with the firm’s exceptional bench is an exciting opportunity, and I look forward to the many collaborative successes we will achieve together,” said Ms. Javitt.

 

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FDA Says That Theranos Discovery Strain Is Causing Other FDA Enforcement Efforts to Take a Backseat

FDA Says That Theranos Discovery Strain Is Causing Other FDA Enforcement Efforts to Take a Backseat

By Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks* —

About eighteen months ago, the government accused former Theranos founder Elizabeth Holmes and former Theranos president Ramesh “Sunny” Balwani of wire fraud and conspiracy, a scheme that fooled investors into providing more than $700 million to the then-promising blood-testing startup.

In the latest development in US vs. Elizabeth Holmes et al., federal prosecutors have asked Judge Davila to extend a December 31, 2019 court-ordered discovery deadline for FDA to produce documents, which the agency failed to meet.  FDA says it needs until April 30, 2020.  We blogged about the prior court order here.  In the January 13 hearing on FDA’s extension request, the agency’s Chief Counsel, Stacy Amin, participated by phone to describe the Agency’s efforts to respond.

Ms. Amin argued that time frame had been too to comply with the large request.  She reported that the Agency had multiple employees working at 200% of their normal capacity in an attempt to meet the court’s initial deadline of December 31, 2019.  Ms. Amin said that several employees and significant resources had been redirected to meet the demand of the court’s discovery request. These strains, she said, have caused FDA to place other regulatory activities on pause, making it difficult for the Agency to meet its public mission to protect public health.  Remarkably, she indicated that even FDA enforcement efforts have taken a backseat to this discovery, including reduced resources for the issuance of warning letters and reduced resources for seeking court injunctions in other cases.  On net, Ms. Amin indicated FDA believes document production can be completed by April 30.

In light of the trial date of August 4, 2020 (mark your calendars!), Holmes’ and Balwani’s counsel argued that April 30 still would not give them enough time to review the material prior to trial.  The prosecution blamed the defense counsel for their predicament, suggesting that the complexity of the search requests had contributed to FDA’s inability to meet the December 31 deadline.

Judge Davila did not make a ruling during the hearing and has not yet issued a written order.  Since FDA has already missed the original deadline, the judge will have to either grant the motion for an extention until April 30 or deny the motion and set a different deadline.

We will continue to provide updates on the Theranos saga as developments occur.  The next court date is February 10, 2020 where the defense’s motions to dismiss will be heard.

*Work supervised by the Firm while DC Bar application is pending

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The Vanishing PMA Device Advisory Panel Meeting

The Vanishing PMA Device Advisory Panel Meeting

By Jeffrey N. Gibbs & McKenzie E. Cato

Under the Federal Food, Drug, and Cosmetic Act, FDA is authorized to hold advisory panel meetings for premarket approval applications (PMAs).  While FDA originally had to hold a panel meeting for all PMAs pursuant to the Medical Device Amendments of 1976, Congress liberalized the law in 1990 so that FDA panel meetings would only occur “on the Secretary of the Department of Health and Human Service’s own initiative” or “upon the request of an applicant unless the Secretary finds that the information in the application . . . substantially duplicates information which has previously been reviewed by a panel.”

As we have noted previously, the number of PMA advisory panels has declined significantly in recent years (see also our prior post here).  Whereas in 2010 there were 9 panel meetings, in 2017 there were only 2.  In 2019, this downward trend hit bottom: there was not a single PMA advisory panel meeting.

To connoisseurs of the device approval process, this was a sad loss.  The PMA panel process provided otherwise inaccessible insights into FDA’s thinking, as well as the ability to analyze the impact of policy changes on substantive decisions (see PMA Advisory Panels: The Impact of FDA’s Change in Policy on Voting Pattern).  And, they sometimes offered traits rarely associated with the application process: drama, excitement, tension, and even humor.

For those who crave device panel meetings, it was not a total loss.  FDA did hold 9 other panel meetings in 2019, on topics ranging from ethylene oxide sterilization to reclassification of surgical stapler devices.  And, there was one advisory panel meeting for a de novo request (the NeuroAD Therapy System for treatment of Alzheimer’s dementia).  One could have gotten good odds on a bet that the number of de novo panel meetings in 2019 (1) would exceed the number of PMA advisory panel meetings (0).

Of course, other types of applications are also subject to panel meetings.  For example, FDA convenes panels to consider applications for new molecular entities.  Still, an article published in the January 9 issue of the Pink Sheet (US FDA’s Breakneck Approval Pace Clashes With Advisory Committee Mandate) reports that number of advisory panel meetings for drugs has dropped significantly in recent years.  If these trends continue, advisory committee meetings to review individual product applications may eventually become extinct.

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