Category Archives: General

FDA Warns Florida Company: CBD Oil is Not a Dietary Supplement

Despite recent bipartisan calls on the FDA to regulate hemp-derived CBD products, the U.S. Food & Drug Administration appears to be adhering to the status quo, at least with respect to issuing warning letters to companies deemed noncompliant with existing regulations. Case in point: on September 18, 2019, the FDA issued a warning letter (posted to the FDA’s website last week) to Alternative Laboratories, a dietary supplement manufacturer based in Naples, Florida.

According to the letter, the FDA conducted an inspection of Alternative’s dietary supplement manufacturing facility over five days in May and June; the inspection focused on the adequacy of labels for certain products manufactured and distributed by the company.

To read the full text of this blog post by Duane Morris attorney Justin M. L. Stern, please visit the Duane Morris Cannabis Industry Blog.

FDA’s New Medical Device Rules Speed Up Review Process

This was originally published in Law360.

With the advancements in technology and the advent of artificial intelligence, the medical device industry is flourishing. But regardless of the type of technology involved, the U.S. Food and Drug Administration must clear the device for marketing before any commercialization of a medical device.

There are typically three mechanisms for seeking FDA clearance for a medical device: a 510(k) submission, a de novo classification request and a premarket approval application. The FDA will not accept a 510(k) application unless the applicant can demonstrate that the device is at least as safe and effective (i.e., substantially equivalent to) a device that has already obtained FDA clearance (i.e., a predicate device).

For the full article by Frederick R. Ball and Carolyn A. Alenci, visit the Duane Morris LLP website.

Duane Morris Recognized by LMG Life Sciences Awards for Role in Hatch-Waxman Impact Case of the Year

Duane Morris LLP was honored for its role in a Hatch-Waxman Impact Case of the Year at the Legal Media Group (LMG) Life Sciences Awards 2019. The case was Teva Pharmaceuticals et al v. Sandoz et al. (Fed. Circ. 2018), where the firm represented Amneal.

Duane Morris was also shortlisted as a “Firm to Watch – Financial & Corporate” and partner Anthony J. Fitzpatrick in Boston was named a finalist for “General Patent Litigator of the Year – New England.”

For more information, read the news release.

FDA Announces Its Next Steps for Cannabis Products

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.

Read the full Alert on the Duane Morris LLP website.

AdvaMed Releases Updated Code of Ethics, Effective 2020

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.

Read the full Duane Morris Alert.

What Competitors Don’t Know Can Hurt You: SCOTUS Rules Secret Sales Can Trigger On-Sale Bar Under AIA

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.

Read the full Duane Morris Alert.

FDA Issues Final Guidance on Data Integrity and Compliance with Drug CGMP

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.

Read the full Duane Morris Alert.

DOJ Implements 2018 Granston Memo on False Claims Act

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.

Read the full Alert on the Duane Morris LLP website.

FDA Announces New UDI Compliance Deadlines via Another Guidance Document

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.

Read the full Alert on the Duane Morris website. 

FDA Withdraws Proposed Generic Drug Labeling Rule

The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels with new information. The proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, would have imposed on generic drug manufacturers the same labeling-update mandates that now apply only to brand-name drug manufacturers.

To read the full text of this Alert, please visit the Duane Morris website.