PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications.  Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed, legislation has been introduced in Congress and a series of legal cases have been brought, …

[Read more...]

Federal Trade Commission Releases New Mobile Health Apps Interactive Tool

The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new web-based interactive tool to assist developers of health-related mobile apps identify …

[Read more...]

Federal Rx for Opioid Epidemic: Tighten Rules on Prescribers

The federal government has made no secret of its concern over what is invariably described as an “opioid epidemic” sweeping the country.  Nor is it a secret that the government sees prescribing physicians—especially primary care physicians—as the best choke point for slowing the flow of …

[Read more...]

OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian devotee apparently works at the U.S. Food and Drug Administration (FDA), which sent a …

[Read more...]

If You Think You’re Safe from FDA Scrutiny Because You’re in an Ivory Tower, Think Again

There is no “cloak of invisibility” for researchers. FDA increases enforcement based on clinical research violations.  According to recently-posted data, 2014 was a banner year for FDA enforcement based on clinical research violations.  The Center for Drug Evaluation and Research (CDER) Office of …

[Read more...]

There’s No Such Thing as Bad Publicity

As of March 3, Solvay Pharmaceuticals is ready to second P.T. Barnum’s famous dictum that there’s no such thing as bad publicity.  That’s the day a federal court in Texas dismissed a qui tam action against Solvay. The whistleblowers filed suit in June 2003, claiming that Solvay paid kickbacks to …

[Read more...]