The FDA has just released its “Guidance on Drug Safety Information” abandoning its own proposed ‘DrugWatch Site Guideliens (2005), http://www.fda.gov/cder/guidance/6657dft.htm replacing it with an *asterisk and an impossible to find location on the Center for Drug Evaluation and Research (CDER) web page.
A mere * is supposed to convey what the agency considers “emerging drug safety issues.”
The Pink sheet reports (below): “Instead of the previously proposed Drug Watch Web site, the agency has launched a Drug-Specific Information Web site under the CDER home page, which will contain information about drugs that are the subject of a public health advisory or an alert. Drugs that are the topic of an active FDA safety alert are identified with a red asterisk. ”
PharmaMarketing Blog puts it this way:
The asterisk is virtually the only new piece of information revealed in the recent “Guidance on Communication of Drug Safety Information” issued by the FDA (see the press release).
First of all, this is a far cry from the Drug Watch Site proposed by the FDA in 2005 (see “FDA Drug Watch Site Guidelines”). http://pharmamkting.blogspot.com/2005/05/fda-drug-watch-site-guidelines.html
Secondly, this is not an “easily accessible link” — at least not from FDA’s home page. On that page, I see a prominent link to “Recalls, Product Safety,” which does NOT concern “emerging” safety information, but full-blown safety disasters! For the consumer and health care professional this is like closing the barn door AFTER the cows have left!
The Guidance directs us to “www.fda.gov/medwatch/safety” to find this page. Go ahead, click on it and see what you get.
Clearly, FDA’s latest smoke and mirrors exercise–which is what this Guidance is–is not geared toward disclosing drug safety issues to the public.
Once again, FDA demonstrates bad faith by putting “new” drug safety information under the control of the very division within the FDA–CDER– that bears responsibility for both approving hazardous drugs that killed thousands of people–and that has been singled out as the major obstacle to drug safety monitoring after drugs have been approved.
Indeed, every independent investigation of FDA’s drug safety performance–including the GAO, the IOM, and the Breckenridge report–each of these independent panels directed their harshest criticism at CDER’s culture of arrogance and secrecy, failing performance, and the cozy relationship of its high ranking staff with industry.
Indeed, CDER officials sought to intimidate and sabotage FDA safety officers who detected drug hazards which they sought to bring to public attention-so that lives could be saved. CDER officials even used criminal investigations as a means of intimidation.
PharmaMarketingBlog got it right:
OK, so now we’ve got an unwieldy URL, a forgettable name, and a “easily accessible” link that cannot be found. This is the new “transparency” that new FDA commish Dr. Andrew C. von Eschenbach is crowing about, albeit in a uncommunicative fashion according to Mark Senak over at Eye On FDA (see “Perception – Reality: The FDA and the Art of Communications”). http://www.eyeonfda.com/eye_on_fda/2007/03/when_going_agai.html
Other than incoherent rambling by FDA Commissioner, Dr. Andrew vonEschenbach, and a Guidance that reduces drug safety to an *, the “reality” is that the FDA has done nothing to advance the communication of drug safety information to the public.
March 02, 2007
CDER Abandons “Drug Watch” Program To Communicate Safety In Favor Of Asterisk
FDA will notify drug sponsors that emerging drug safety data will be posted on the Center for Drug Evaluation and Research Web site at least 24 hours before the information is communicated, the agency says in a final guidance issued March 2 outlining how FDA plans to communicate drug safety information to the public.
“Today’s document captures the evolution of our thinking since the initial issuance of the draft guidance in May 2005,” CDER’s Associate Director for Safety Policy and Communication Paul Seligman stated during a same-day press briefing on the guidance.
“The feedback we have received to date from patients, providers, as well as from staff internally at CDER … has been uniformly positive and in strong support of the need to get out emerging information in a timely, fair, balanced and impartial way,” he said.
The final guidance, however, does diverge from the draft guidance in the way FDA plans to communicate this emerging information to the public. Instead of the previously proposed Drug Watch Web site, the agency has launched a Drug-Specific Information Web site under the CDER home page, which will contain information about drugs that are the subject of a public health advisory or an alert. Drugs that are the topic of an active FDA safety alert are identified with a red asterisk.
The agency’s draft guidance included plans to develop a Drug Watch Web site to list drugs it considered as having significant emerging risks (1″The Pink Sheet” DAILY, May 5, 2005 <http://www.thepinksheetdaily.com/fdcreports/story/viewStory.do?targetAN=14050505002> ). The concept had been criticized however, and more recently, its fate appeared to be in question (2″The Pink Sheet” DAILY, Sept. 11, 2006 <http://www.thepinksheetdaily.com/fdcreports/story/viewStory.do?targetAN=14060911004> ).
“A concern expressed by some who commented on the May 2005 draft was the use of the proposed ‘Drug Watch’ name for this initiative, and the potential to confuse it with the long-standing MedWatch program,” Seligman said.
As far as the decision to use a red asterisk to communicate safety information, the FDAer said, “I feel strongly that such an approach readily achieves our goal, alerting those who need to know that a drug has recent safety information that should be considered in making prescribing and use decisions.”
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– Jessica Merrill (email@example.com)
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