New FDA Commissioner wants to “enforce the Act.”

June 17, 2009

Update 3: The government columnist for Applied Clinical Trials, Jill Wechsler, writes about the increased enforcement of good clinical practice regulations for clinical trials. See the link in interesting articles, Applied Clinical Trials…

In her first discussion of her goals and priorities for FDA with the media, new FDA Commissioner Dr. Margaret Hamburg made it clear that she would place an increased emphasis on enforcement. When I conducted FDA inspections (1993-2005) we used to call this, “enforcing the Act.” We saw our primary job as enforcement of the US Food Drug & Cosmetic Act, which we modestly referred to as the “foremost consumer protection law in the world.” I am attaching a NY Times article (1: New FDA chief says she’ll toughen enforcement standards) that describes Hamburg’s new emphasis on enforcement activities (see Blogroll on the right). The Times also reports that FDA warns against using Zicam, a popular cold remedy that evidently can destroy your sense of smell (see NY Times website).

Update: Matrixx defends Zicam, read their views under Interesting Articles on the right (scroll down).

Update 2: Time seems to think that FDA is getting tougher. See: 2 Is FDA Getting Tougher on the blogroll

Update 3: Take a look at Dr. Hamburg’s speech to FDLI in the latest 2 posts. This post has been confirmed!

Read the NY Times Article:

Tobacco heads to the House

June 12, 2009

Ted Kennedy’s bill to allow FDA to regulate tobacco passed by a wide margin in the US Senate and now moves to the House of Representatives. For the first time the tobacco companies will have to list ingredients in cigarettes. That sounds pretty good to me. However, I have serious concerns regarding FDA taking over an addictive product (see post below). However, as usual, they forgot to ask me. I am attaching the Washington Post’s take on it all under Interesting Articles “Bill Heads to House.”

Update: Under blogroll NY Times on Tobacco Bedfellows you can read the interesting story of how three unlikely partners worked together on behalf of FDA regulating tobacco.

UPDATE: See this interesting analysis for Seattle under Interesting articles on the right, scroll down until Bill on Tobacco spurs debate. Soon I will return to views on clinical trials.

Update: Wouldn’t you know it. WordPress has changed how to add links and I just don’t understand it. When up against a bureaucracy, WordPress is pretty fierce. Look at the blogroll under DC Freedom. WordPress isn’t letting me post links elsewhere.

Should FDA take on tobacco?

June 8, 2009

Senator Ted Kennedy, a longtime foe of the tobacco industry, has introduced legislation to have FDA regulate tobacco. Strange bedfellows have emerged with tobacco giant Philip Morris joining Kennedy and the Campaign for Tobacco-Free Kids for FDA regulation. Not everyone is impressed. I’m putting a link to an interview with libertarian author Patrick Basham who has just published Butt Out! How Philip Morris burned Ted Kennedy, the FDA, and the Anti-Tobacco Movement. The interview is under Interesting Articles (scroll down on the right) under, Butt Out!

The first time FDA tried to regulate drugs I was the “Tobacco Monitor” for the San Francisco District of FDA. With most of the regulation in court, the program concentrated on funding state programs to stop sales to minors. The whole thing never really got off the ground and caused a certain amount of resentment in the FDA workforce.

I’m not very sure FDA is the best organization to regulate tobacco. Someone once had the bright idea that FDA should regulate methadone clinics. I was involved in those inspections which were really an inappropriate use of Agency resources. The program was finally transferred to a mental health agency, SAMSHA, where it belonged. I’m not sure who should regulate tobacco, it certainly needs it, but I’m not sure that FDA is the right place. It really doesn’t fit in with FDA’s public health mission. There are No safe cigarettes.

That being said, the opposition to Kennedy’s bill is led by RJ Reynolds, the number two tobacco giant. They talk about “smokeless innovation” and “harm reduction.” I am not convinced at all. Anyway, the debate is starting up and it should be interesting. If it passes it will be quite a challenge for new FDA Commissioner Margaret Hamburg. I don’t envy her.

UPDATE: It looks like FDA regulation of tobacco is drawing close. See Boston Globe Tobacco, under Interesting Articles for a pretty good update.

Hamburg and Sharfstein make their opening statement on the role of FDA

June 2, 2009

Dr. Margaret Hamburg and Dr. Joshua Sharstein, the new leadership of FDA, have made their opening statement in an article published 26 May 09 in the New England Journal of Medicine entitled, ” The FDA as a Public Health Service.” There they discuss their vision for the future of FDA. The first thing I noticed is that they published their article in a medical journal that will not reach most American consumers. That is really too bad. They should have used a different venue such as the NY Times. Oh well. If I wasn’t in the FDA Alumni Association I would have never known. You can read it under Interesting Articles on the right under Hamburg & Sharfstein in the NEJM. Scroll down to find it. At least they are talking, which is a start.

UPDATE: If you wish to hear Dr. Hamburg for yourself, she will be speaking at the closing plenary session of the Regulatory Affairs Professionals Society (RAPS) annual meeting in Philadelphia on the 16th of September. You can read about it on the Blogroll on the right under “RAPS.”

UPDATE 2: I have added two new sites to the Blogroll. One is a health oriented site that discusses today’s 3 June 09 NY Times editorial on FDA secrecy (365 Days Health Blog) and A world news service from France in English (France 24).

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