Health Law Advisor Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

Tag Archives: Prescription Drugs

Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments – April 2017

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, DC, on April 6-7, 2017. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC’s meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC’s next report to Congress.

As thought leaders in health law, Epstein Becker Green monitors MedPAC developments to … Continue Reading

Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter?

When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA’s position, Twitter was not going to be a medium that drug and device companies could use to effectively promote their products. Sure, companies … Continue Reading

FDA’s Wholesale Distributor and 3PL Reporting Requirements Draft Guidance Provides Some Clarity Not Found in Previous Draft Guidance

FDA is the subject of a lot of criticism, some deserved, and some not.  However, I don’t think FDA gets enough praise when it does something right.  Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.

Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with FDA as a wholesale distributor or 3PL as required by the DSCSA.  This clarification likely has the … Continue Reading

FDA’s Second Guidance on the Drug Supply Chain Security Act Misses the Mark

FDA’s Second Guidance on the Drug Supply Chain Security Act Misses the Mark

Although FDA appropriately identified the need for guidance on the Effect of Section 585 of the FD&C Act on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.

In November 2013, Congress enacted the Drug Supply Chain Security Act (“DSCSA”) with the intent of establishing a “Uniform National Policy” for wholesale distributor and third party logistics provider (“3PL”) licensure.  Congress hoped to achieve this goal by adding Section 585 to the Federal Food Drug and Cosmetics Act (FD&C Act) which … Continue Reading

FDA Releases Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

by Wendy C. Goldstein and Kathleen A. Peterson

On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.

The FDA has a longstanding policy of permitting pharmaceutical manufacturers to respond to unsolicited requests for medical information about their products, even where such information pertains … Continue Reading