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.
Industry Insights
OPDP Issues Two Enforcement Letters: Continuing Focus on Promotion of Drugs with Serious Risks & Drugs for Diseases With Significant Public Health Concerns
By: Alan G. Minsk and Seth S. Ray
On September 13, 2019, FDA’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter stating that a professional email made false or misleading claims and representations about the risks and effectiveness associated with the use of a drug for treating insomnia. Eleven days later, OPDP sent an Untitled Letter alleging that a direct-to-consumer patient testimonial video montage posted on YouTube.com presented false or misleading claims and representations about the risks associated with a drug for high cholesterol. More >
Medical Device Developments: FDA Finalizes Four 510(k) Guidance Documents
By: Alan G. Minsk and Christine Kirk
In September, the U.S. Food and Drug Administration issued multiple final guidance documents related to the medical device program. In this Bulletin, we briefly address final guidances on the Special 510(k) Program, the Abbreviated 510(k) Program, the Format for Traditional and Abbreviated 510(k)s, and the Refuse to Accept Policy for 510(k)s. These final guidance documents are part of FDA’s ongoing efforts to streamline and improve the 510(k) program and device regulation more generally. Notable items include some changes in the Special 510(k) guidance from the draft to final versions, and the replacement of a previous (1998) guidance by the final Special 510(k) and Abbreviated 510(k) guidance. More >
FDA Considers How to Evaluate the Safety of the Materials Used in Medical Devices
By: Alan G. Minsk and Genevieve M. Razick
On September 30, 2019, Jeff Shuren, Director of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a statement to announce the most recent updates to the agency’s attempts to evaluate the safety of the materials used in medical devices. The statement follows Director Shuren’s March 2019 announcement, which stated that a growing body of evidence suggests that some patients may have a predisposition to a biological response, such as an immune or inflammatory reaction, to certain types of materials in implantable or insertable medical devices. The reaction, however, may not develop until years after implantation and, therefore, the predisposition may be difficult to detect in clinical trials. More >
