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A Crucial Senate Vote on Scientific Integrity at the FDA

Burr amendments would weaken Harkin-Enzi bill

On Wednesday, April 25, 2012, the Senate's Health, Education, Labor and Pensions Committee is scheduled to consider the Food and Drug Administration Safety and Innovation Act, a bipartisan bill proposed by Senators Tom Harkin (D-IA) and Michael Enzi (R-WY).

The Harkin-Enzi bill would strengthen the FDA:

  • It will make it easier for the FDA to require that more scrutiny be given to the highest-risk devices before they can be sold;
  • It ensures that the public will know when the FDA permits experts with financial ties to the device and drug industries to serve on advisory panels;
  • It helps the FDA identify emerging hazards for medical devices that are on the market.
  • It strengthens FDA efforts to identify and track all medical devices, so that patients can be warned if there is a recall of a dangerous device.

However, Senator Richard Burr (R-NC) has proposed amendments that would threaten scientific integrity at the FDA and make it more difficult for FDA scientists to protect the public from unsafe drugs and devices.

Burr's proposal would weaken the Harkin-Enzi bill:

  • It turns current law on its head: instead of the FDA requiring medical device companies to prove that their products are safe, the FDA would have to prove that the products under review are unsafe, and that their risks outweigh their potential benefits.
  • It could allow medical devices to be sold in the U.S. if they meet foreign standards that are much less stringent than the FDA’s already inadequate standards.
  • It would make it harder for the FDA to recruit members of FDA advisory panels who do not have financial ties to drug and device companies. The new obligations and reporting burdens it imposes on prospective advisory panel members will discourage un-conflicted physicians and researchers from applying for slots, and tip the balance in favor of members with a vested interest in the outcome.
  • It will require the FDA to review all its previous regulations to see if their costs to industry justify their benefits. This task, which must be completed within one year, will divert FDA staff from its crucial work of protecting public health and safety.
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