“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugs—but in fact it was about something quite different: a new FDA draft guidance that would change the rules on the distribution of medical journal articles on unapproved uses of drugs.

Pharma has long distributed reprints on off-label uses of drugs, but the rules in recent years were onerous, and, of course, the HHS Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a particularly pernicious form of Medicare fraud. So the real questions for pharma, which weren’t addressed in any of the news articles I read are:

1. Just how new is the new guidance, and
2. How much protection from OIG will the guidance offer if it is ever finalized (more about that in a moment).

The answers: (more…)

Cynthia Phillips (right), director of regulatory advertising at Shire HGT, closed this year’s ePharma Summit with a conversation about managing regulatory risks in the world of Web 2.0. Here are some of her comments:

Is the Web promotional labeling? DDMAC does not want to tell us what it is thinking; it just wants to hit us when we mess up. The more we get into Web 2.0, the bigger liability we have. Is the Web truly promotional labeling, or is it DTC? And should Web promotion receive DTC regulations?

Too conservative? Pharma is slow to react, and it is under a lot of pressure. I personally would like to see the industry push the envelope in advertising.

Free speech If the dialogue on a social-network site turns off-label, we start getting into the First Amendment issue. How do you handle that, or do you stop the conversation at that point? The legal people I talk to are very tense about that.

Social networks as research I love the idea of monitoring social networks as marketing research, provided someone synthesizes it for you. That information is extremely valuable.

If you follow any news from the HIV/AIDS market at all, no doubt you’re like us—waiting on pins and needles to hear if FDA will approve Tibotec’s non-nucleoside reverse transcriptase inhibitor, TMC125.

The drug was accepted for priority review by FDA, with a PDUFA date of today. I got tired of checking the company’s Web site every five minutes, so I rang them—but still no word.

“Having been through this process many times, I can tell you, we probably won’t hear until late in the day,” said a spokesperson for the company. But there’s a lot of excitement inside the company, and the PR department has been busy working on press materials all day. (more…)

European news sources are reporting that European Union officials conducted surprise dawn raids Wednesday at the offices of a number of pharmaceutical companies, including Pfizer, GlaxoSmithKline, Sanofi-Aventis, AstraZeneca, Merck Sharp & Dohme, Johnson & Johnson’s Belgian unit, Wyeth, and Novartis’ Sandoz division.

What’s the beef? Reports say the EU is looking for evidence of patent abuse. Here’s how the AP described it: (more…)

The award for goofiest attack on the FDA this week has to go to Senator Sherrod Brown (D-OH), who has asked the Congressional Research Service to look into the possibility of changing or eliminating FDA’s Fast Track designation, according to the Cleveland Plain Dealer.

The Plain Dealer no doubt thinks this makes sense. Last December, the paper published a series of articles revealing that (a) Fast Track designation doesn’t really seem to get drugs to market that much faster, and that most of what it provides can also be provided under the older Priority Review programs, (b) the announcement of Fast Track designation pumps up both stock price and trading volume for biotechs, and (c) there’s pretty persuasive evidence that some execs are playing such announcements to enhance the value of their stock options.

(You can read the series here, here, here, here, and here.) (more…)

FDA has launched a nationwide search for Director, Center for Drug Evaluation and Research (CDER). The open period for applications continues through Friday, February 1, 2008. The detailed job announcement and instructions for applying are available on the USAJOBS site. See Job Announcement Number FDA-AD-2008-01. (more…)