FDA: Stifler or Savior?

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Controversy has arisen in the diabetes community in recent weeks because of an announcement by the Food and Drug Administration (FDA) about changing the standards for approving new diabetes drugs.

First came the news that the FDA will require more rigorous testing of new diabetes drugs before they are approved, to make sure that they not only lower blood sugar levels, but also don’t increase risks for other serious conditions, such as heart disease. This will mean that companies must sponsor longer trials and include more high-risk participants in those trials before their new drugs will be approved.

Read more about the new requirements in the articles “FDA raises the bar for new diabetes drugs” and “FDA Wants New Diabetes Drugs Tested for Heart Risks.”

“I think the FDA got this one right,” says Steven Nissen, MD, the doctor who carried out the meta-analysis that in 2007 linked the diabetes drug Avandia to an increased risk of heart attacks, in the first article.

But now, several diabetes bloggers are pushing back. “While this sounds reasonable on the surface,” Amy Tenderich writes at Diabetes Mine, “…what they’re actually doing is creating excessive regulatory hurdles that serve only to ensure the continued use of the very drugs and devices that have proven ineffective for so many patients.”

Tenderich, along with Allison Blass (Lemonade Life), Kerri Morrone Sparling (Six Until Me), and several other diabetes advocates (most with Type 1 diabetes), have cosponsored a petition entitled “Ask the FDA to Better Serve Diabetes Patients’ Needs,” which can be found at www.healthefda.com.

Here are some excerpts from the petition:

[W]e believe the FDA has adopted a stance of excessive caution in its regulation of diabetes drugs and technology that is counter to its duty to serve patient needs.

Specifically, it has established new rules that will impair research and innovation into diabetes therapy….

Ironically, excessive regulatory hurdles ensure the continued use of the very drugs and devices that have proven ineffective for many patients.

There is no value in an ideal diabetes drug or device if the regulatory costs are so great that the product never makes it to market. Make rules reasonable.

The petition asks that the FDA create a “Diabetes Advisory Council” that would include practicing endocrinologists, diabetes educators, and other professionals who have direct contact with patients, rather than just researchers.

Do you think the FDA’s new requirements are a step in the right direction, or go too far? Will they help make diabetes drugs safer, or stifle innovation? Have you signed the petition? And where are the voices of people with Type 2 diabetes on this issue? Comment now!

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