Time to speak up—loudly
As I write this, our senators in Washington, D.C. are patting themselves on the back over a bill they passed that they say is needed to give the FDA more authority over the prescription drug market.
Naturally, this is politics, so it’s not what it seems—it’s much worse. And as you know, I don’t usually use the space to talk politics but when your health is at stake I can’t keep quiet—and neither should you.
I’m referring to Senate bill S-1082, the Prescription Drug User Fee Act (PDUFA). It’s also known by other names such as the FDA Revitalization Act and others that I shouldn’t repeat.
Among other things, the bill requires the drug companies to pay the FDA “user fees” to approve new drugs before they’re put on the market. The problem is that these “user fees” now make up more than half of the FDA’s total budget, so who is the FDA really working for? Who is the FDA really interested in protecting—us, or the FDA? We only have to look at all the FDA has already protected us from (Vioxx, Ketek and a couple others) to answer that question.
And you only have to look at what didn’t make it in the bill to understand who is being protected. Of course, I’m talking about a proposal that would have legalized the importation of lower-priced drugs from Canada. Again, Big Pharma won that lobbying battle and millions of Americans have to either sneak across the border like thieves in the night or continue to pay the highest prices in the world for prescription medications.
It’s a glaring, unspoken admission as to who and what our government is really interested in protecting.
Now, please don’t get me wrong. I’m not saying that we need to start raising taxes so more of our money goes to the FDA. I’m saying that we need to bring back some common sense and bring back the original intent of the FDA—to protect you and me from the likes of Big Pharma, not partner with them!
Some senators will tell you that the bill will give the FDA more power than it had. For instance, the bill would give the FDA new power to track drug safety and maintain a public web site of clinical trials, authorization to order changes in drug labeling, authority to regulate advertising, and the ability to restrict use of risky medications. This bill is set to move on to the House for approval, possibly as early as July, before the current PDUFA expires in September.
But these new powers are just token gestures—nothing more!
That’s because everything else in the bill just strengthens the cozy relationship between the FDA and Big Pharma. For instance, the bill also calls for a safety oversight board that would, get this—enter into drug safety “collaborations,” with none other than people that are deemed to have expertise in drug safety and research. In particular, they must have an understanding of “drug development and risk/benefit balance in a clinical setting,” and have a “significant business presence in the U.S.”
In other words, this so-called safety oversight board will be made up of pharmaceutical and biotech companies, and we know how well they understand “risk/benefit balance”.
One interesting aspect of the bill is the establishment of the nonprofit Reagan-Udall Foundation for the FDA—which in effect, means they’re now in business. Despite the bill specifically stating that it is not an agency or an arm of the U.S. Government, the purpose of the foundation is to advance the mission of the FDA of modernizing product development, accelerating innovation, and enhancing product safety.
Sounds like an arm of a government agency—the FDA—to me!
The foundation will be able to award grants and enter into contracts and agreements with scientists and entities—including the FDA—and universities, as well as public-private partnerships. All of which receive, if the partnerships aren’t actually drug companies, at least receive their funding from none other than pharmaceutical companies.
Also, they’re tasked with providing “objective” clinical and scientific information to the FDA to make sure that regulatory policy accommodates scientific advances and meets the public health mission of the FDA (i.e. develop more drugs, faster, according to their own mission statement).
And who will be the appointed members of the foundation? None other than representatives from: the pharmaceutical and biotech industries, university research branches, the government (including the FDA), and token appointments of representatives of patient advocacy groups and health care providers.
How “objective” a view can they possibly offer, considering where they hail from?
I don’t want to be cynical—I want to be proactive. I will continue to monitor this matter, as it has such far-reaching implications for the state of healthcare in this country, and this is not the time to turn a blind eye.
When money talks, it can crowd out the voices of reason. If talking doesn’t work, then let’s shout, and continue to beat the drum in order to preserve our safety and get the FDA out of Big Pharma’s pockets. You still have time—contact your House representatives and make your voice heard. Go to www.house.gov/writerep/ and let your Congressman know how you feel about S-1082.
