It seems that almost every month, we hear yet another news story about problems at the U.S. Food and Drug Administration. Last December, even an internal report produced by the FDA itself entitled “FDA Science and Mission at Risk” (which can also be found at the Food and Drug Administration’s website) concluded that the FDA was desperately short of money and poorly organized, which is putting people’s lives at risk. This has Congressional lawmakers finally giving more serious consideration to their oversight (or rather, their lack of oversight) for the FDA, but money won’t solve all the Agency’s issues, more careful oversight is needed, too.
Back in early March 2008, I wrote that the U.S. Food and Drug Administration was soliciting public comments on the Agency’s Draft Guidance for Diabetes Treatments (relevant to both drugs and biologic medicines). If ever there was an issue of importance to patients with diabetes, it is surely regulatory guidance on diabetes medicines. The deadline for public comments ended 2 weeks ago.
Naturally, I submitted a host of comments (8 pages to be precise) related to the draft guidance, although most of my comments pertained to type 1 diabetes since that impacts me personally. Although the FDA has not included individual comments in the docket (I suspect because they’ll need to redact personal address information before making it available to comply with Federal policy), you might find the comments submitted by the pharmaceutical industry and their trade organizations such as PhRMA and BIO interesting reading (see the regulations.gov website here). I was heartened by the fact that the Juvenile Diabetes Research Foundation (JDRF) even submitted comments (although I think they missed many opportunities to advocate towards guidance that encourages cure therapeutics), but the organization did respond to the issue, and for that, they should be commended. Amazingly, however, the nation’s largest, self-appointed diabetes advocacy organization, the American Diabetes Association was silent on this issue.
SILENT!
As my title suggests, the ADA’s silence was deafening. How can an organization whose 501(C)3 status claims that its mission statement is “to prevent and cure diabetes and to improve the lives of all people affected by diabetes” have remained silent on this issue? These guidelines will outline how drug and biopharmaceutical companies develop, test and validate the safety and efficacy of new diabetes treatments for the next decade (if not longer) and the American Diabetes Association had no comments?!!? This is unacceptable!
EVERYONE in the diabetes community should be asking who’s asleep at the wheel over there at the ADA’s headquarters in Alexandria, Virginia?
If ever we needed validation that the American Diabetes Association is a wholly-owned subsidiary of big pharma and agriculture, surely this is it. You can, and should express your displeasure by writing to the ADA. But I would encourage you to avoid their general correspondence address, and instead direct your letters to the executives who run the organization (including John Buse, the current President) at the organization’s headquarters’ address:
John B. Buse, MD, PhD
American Diabetes Association
1701 N. Beauregard St
Alexandria, VA 22311
Tel: (703) 549-1500
The ADA also offers a toll-free support line at 1-800-DIABETES (1-800-342-2383) which is operational from Monday-Friday, 8:30 AM - 8:00 PM EST, but realize you are calling a call-center, not the organization’s headquarters. By the way, the American Diabetes Association’s IRS tax filings are available for the public to view at the Foundation Center’s website, there you can see exactly what the ADA is spending its money on, where the money is coming from and how much key executives are being paid for their work.