The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The updated list will provide greater transparency regarding Paragraph IV certifications and potential exclusivities. That transparency will in turn lead to greater predictability for generic manufacturers regarding the potential timing of approval for their ANDAs and the potential degree of competition. The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.
At the U.S. Food and Drug Administration’s (FDA) public hearing on May 31, 2019 (read more about the hearing), over 100 people presented to a panel of FDA stakeholders and to over 500 attendees. Last week, FDA stated in a post that it recognizes the “significant public interest in these products, for therapeutic purposes and otherwise” but reiterated that “there are many unanswered questions about the science, safety, and quality of many of these products.”
The good news for the industry is that FDA “recognize[s] the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward,” including “being transparent and up-front” as they continue to collect data and information on CBD. FDA is taking an “Agency-wide, integrated, and collaborative approach” to regulating products made from CBD and is exploring potential pathways to market for CBD products. However, FDA still grapples with how to balance the desire for widespread availability of CBD products with the desire to preserve incentives for research and drug development of CBD products.
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for a recall; (2) response to a reported problem with a product; (3) initiation of a recall; and (4) FDA’s role in initiation of a recall. As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.
With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country. However, the U.S. Food and Drug Administration’s (FDA) press release issued that same day put a hold on the jubilation, stating that FDA considered any and all cannabis-containing or cannabis-derived products as drug products and not food or dietary supplements, regardless of whether the CBD was hemp-derived.
On April 2, 2019, departing FDA Commissioner Scott Gottlieb issued a statement about FDA’s next steps to advance a regulatory pathway for cannabis-containing and cannabis-derived products. At the same time FDA updated its cannabis-containing products and cannabis-derived products Q&A. It is clear that, at this point, FDA has not changed its position.
The Advanced Medical Technology Association (AdvaMed) has published its updated Code of Ethics. The updated code will become effective on January 1, 2020. AdvaMed has also published an overview of changes.
The updated AdvaMed Code now includes “Key Concepts” at the beginning of each section, with visuals, graphics, callout boxes, examples, explanations and FAQs.
The AdvaMed Code provides medical technology companies with guidance on ethical interactions and relationships with healthcare professionals (HCPs) to ensure that medical decisions are based on the best interests of the patient.
Because the medical technology industry is highly divergent, the AdvaMed Code drafters recognize no single compliance program fits each company. Therefore, AdvaMed encourages companies to adopt an “appropriately tailored” ethics and compliance program, accounting for the specific types of risks that apply to their operations. Companies adopting the AdvaMed Code are encouraged to submit to AdvaMed an annual certification stating adoption of the AdvaMed Code and implementation an effective compliance program.
The Supreme Court of the United States recently affirmed the decision of the U.S. Court of Appeals for the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals, 855 F.3d 1356 (2017), which invalidated a patent-in-suit under the post-AIA on-sale bar. The question presented, answered by the Court in the affirmative, was “[w]hether, under the Leahy-Smith America Invents Act [AIA], an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”
Justice Thomas, writing for the Court, concluded that the “on sale” provision in §102(a)(1) of the AIA was a re-enactment of the “on sale” bar provision in the pre-AIA patent statute that did not alter its meaning or interpretation, despite the inclusion of the phrase “or otherwise available to the public” in post-AIA §102(a)(1). Thus, based on the Federal Circuit’s “settled precedent,” and consistent with the Supreme Court’s decision in Pfaff v. Wells Electronics, 525 U.S. 55 (1998), the Court held that “a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on sale’ under [the AIA].” Details of the ruling and some takeaways for companies entering into licenses and supply agreements are discussed below.
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product quality and public safety. In response to an increased number of data integrity violations, which have led to warning letters, import alerts and consent decrees, the FDA published a draft guidance on Data Integrity and Compliance with CGMP on April 14, 2016. After considering comments to the draft guidance, the FDA has now issued its Final Guidance on Data Integrity and Compliance with Drug CGMP on December 12, 2018. The Final Guidance is in a Q&A format and provides detailed instructions to the industry that reflects the FDA’s current thinking on data integrity.
In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) cases to seek dismissal of qui tam complaints that threaten the government’s interests. However, it was unclear how and to what extent prosecutors would carry out that directive. Now a year later, federal prosecutors appear to be embracing the new policy—and it is already having an effect on one case involving a drug manufacturer.
The January 2018 Granston memorandum outlined the Department’s new approach to handling FCA prosecutions in “in light of the government’s limited resources.” Under the new policy, prosecutors are encouraged to move to dismiss qui tam claims as a way to “advance the government’s interests, preserve limited resources, and avoid adverse precedent.” This marked a departure from the Department’s previous policy of rarely exercising its statutory authority to dismiss such claims. To guide prosecutors, the memorandum offered a nonexhaustive list of factors as to when a motion to dismiss a qui tam claim is proper. Those factors include: (1) “curbing meritless qui tams”; (2) “preventing parasitic or opportunistic qui tam actions”; (3) “preventing interference with agency policies and programs”; (4) “controlling litigation brought on behalf of the United States”; (5) “safeguarding classified information and national security interests”; (6) “preserving government resources”; and (7) “addressing egregious procedural errors.” Overall, the memorandum instructed prosecutors to seek dismissal when the litigation does not serve the government’s interests.
On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately identify devices through distribution and use. The FDA has since issued several guidances updating implementation of the unique device identifier (UDI). On November 5, 2018, the FDA issued its latest UDI policy, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” which supersedes the direct marking deadlines mandated by an earlier guidance.