Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.
In this Issue
Industry Insights
PHARMACEUTICALS
FDA Streamlines the Expanded Access Approval Process for Individual Patients
By: Alan K. Parver and Cathy M. Fortney
The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner Robert Califf announced recently the release of a new form designed to help expedite the process for physicians to obtain “expanded access” or “compassionate use” approval for investigational new drugs (INDs) and biologics for individual patients. Under the Federal Food, Drug and Cosmetic Act (FDCA), a physician may request expanded access to investigation new drugs and biologics, and the request must meet certain criteria for FDA to authorize expanded access (FDA says that it approves 99 percent of requests). Individual patient expanded access submissions made by private physicians are submitted as new INDs. The new Form FDA 3926, Individual Patient Expanded Access Investigational New Drug, was created to ease the paperwork burden on physicians seeking approval for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative is available. More >
Second Circuit Affirms Dismissal of False Claims Act Suit Based on “Off-Label” Marketing
By: W. Jerad Rissler
The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs. The Second Circuit agreed with the district court’s conclusion that the qui tam complaint at issue failed to allege any “off-label” promotion or prescriptions and affirmed the district court’s dismissal on that basis. It added (though it made clear that it was not deciding the issue and that its holding was not based on this reasoning) that it was “skeptical” that “off-label” promotion could lead to FCA liability, at least where the “off-label” promotion is not “for a purpose obviously not contemplated by the label.” More >
MEDICAL DEVICES
FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices by Device Manufacturers
By: Alan G. Minsk
On June 10, 2016, the Food and Drug Administration issued a draft guidance for industry and agency staff entitled, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” FDA will accept comments for 60 days from that date. While not legally binding on FDA or industry, the draft offers the agency’s current thinking and recommendations on how medical device companies can share certain information with patients. More >
COSMETICS
The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs
By: Alan G. Minsk
The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a trend we are seeing where the agency, whether at Headquarters or at the District Office level, will take action against products with purported cosmetic claims that FDA contends are unapproved new drugs. As Cat Stevens sang, “The first cut is the deepest.” More >
NEWS FROM WASHINGTON
Guidance on Effective Self-Disclosure of FCPA Violations for Life Sciences Companies
By: Michael E. Burke
Every life sciences company with international operations should have a robust Foreign Corrupt Practices Act (FCPA) compliance program as part of its overall compliance strategy. On April 5, 2016, the Justice Department announced the launch of a one-year pilot program (Pilot Program) focused on the scope of credit that companies can expect to receive for self-disclosing FCPA violations. On the same day, the Justice Department also announced that it had increased the amount of resources devoted to the investigation and prosecution of FCPA cases. The announcement of the Pilot Program left many FCPA practitioners unclear as to the specific steps a company must take in order to receive ‘credit’ under the Pilot Program. More >