Big Pharma "trade secrets" a thing of the past?
Could it be? Is the FDA really preparing to open their records to the public? Are they making a move toward transparency? The answer is (to me, a hesitant) yes, if recent news is to be believed. Earlier this month, FDA Commissioner Margaret Hamburg announced that she's created a task force that, six months from now, will report recommendations on how the agency can be more open in areas like drug evaluation. One of the biggest questions they face is what to do with unpublished clinical trial data received from drug companies. This data is not normally released to the public, despite the fact that problems with drugs often show up very early in trials. A point on which the FDA has been strongly criticized— withholding potentially life-saving data on the grounds of protecting companies' trade secrets is never right. We've seen countless stories of the FDA waiting too long to release trial data, and the tragic consequences of their fence-sitting (Vioxx, countless anti-depressants, etc.). Of course, Big Pharma won't stand idly by as the FDA pulls the curtain back on what could be some highly damaging data. In fact, a spokesman for the Pharmaceutical Research and Manufacturers of America (Big Pharma's main lobbying group) said, "Any proposal to disclose information about medicines during the FDA review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health." That's a heck of a spin. The translation, of course is: "Transparency is all well and good, as long as it doesn't stand in the way of our $$$." It's time to end the age of the "trade secret." Frankly, I don't care about undermining competition. The #1 goal of the FDA should be to protect the safety of the public. And that means giving doctors and patients all of the information they need to fully weigh the risks and benefits of a drug. The task force will consult industry, medical researchers, and consumer groups as it develops recommendations. Of course, I think the only interests they should have in mind are those of the public that should be protected by the FDA, but I suppose this is a start. As part of this process, the FDA launched the "FDA Transparency Blog" earlier this month. Each week, the blog will ask a new question, and you're free to weigh in. There is also a public meeting concerning FDA transparency on June 24 in Washington, DC. Among the topics discussed will be access to information about product approvals and recalls. The meeting is free to attend, and you can find more information about it here. Who knows what the FDA will do with the feedback that comes from the blog and meeting? The best we can do is speak our opinions loud and clear, and hope that these actions mark a move toward real change. Sources:
"Food and drug agency to study greater openness." Associated Press (news.yahoo.com), 6/2/09.
"FDA aims to make its decisions more transparent." Reuters (www.reuters.com), 6/2/08.
"FDA introduces "Transparency Blog" to gather public input online." The Benninger Blog (www.naturalproductsinsider.com), 6/8/09. | 
