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Sheldon Bradshaw left his post as the Food and Drug Administration’s chief counsel earlier this month. He started his career in public service as one of President George W. Bush’s first appointees at the Justice Department. Bradshaw left the FDA to co-chair Hunton & Williams’ FDA practice, just as Congress is evaluating critical FDA legislation, and the Supreme Court is preparing to possibly hear a major FDA case. Bradshaw spoke with Legal Times reporter Marisa McQuilken last week about all the attention currently focused on the FDA. This is an edited transcript.
LT: What motivated your return to private practice? Bradshaw: As a political appointee, I was eventually going to have to head back to the private sector. What I really wanted was a firm, like Hunton & Williams, that wanted to have a strong food and drug practice, and was willing to invest to make that happen.
LT: Now that you’re in the private sector, what’s your take on the situation at Justice? Bradshaw: I still have a number of friends who are at the Office of Legal Counsel, and a number of friends in the Civil Rights Division, but a lot of my old colleagues have left the department. It is one of the great institutions in American government, and it’s sad that it’s in such turmoil.
LT: The Food and Drug Act is set to expire Sept. 30. Will the reauthorization bill pass in time? Bradshaw: I’m told they’re going to try to move heaven and earth to get that done. Otherwise, there could be very substantial layoffs at the FDA if the major funding streams dry up on Sept. 30.
LT: What major changes does the reauthorization bill propose, and what do they mean for FDA lawyers in the private practice? Bradshaw: Where you see the dramatic changes are in the drug safety provisions that are being added for the first time. These would give the FDA additional authorities in a number of areas that the FDA deems important. For example, right now a number of drugs are approved contingent on some sort of risk management plan. The whole idea of these additional authorities is to give the FDA even more authority to impose these sorts of risk management plans. It might be everything from a limited distribution, to perhaps some requirements for the setting in which a drug could be prescribed. As they [lawyers representing drug companies] work with the FDA, they’re going to have to start thinking about what a risk management plan ought to look like for a particular drug.
LT: Protesters were at the FDA recently to demand that experimental cancer drugs get fast-tracked to approval. What’s your take on this? Bradshaw: The FDA’s hearing it from both sides, that whatever it does, it’s either approving it too quickly or too slowly. I actually am personally of the view that there has been sort of a negative fallout from all of the hammering on the FDA from people on the Hill, like the Senator Grassleys of the world. I think the agency is being too cautious in some areas, but I think that’s a perfectly appropriate response to the beating it has been taking at the hands of members of Congress.
LT: The Supreme Court may soon hear a big FDA case, Riegel v. Medtronic. The question is whether the medical devices amendment to the Food Drug and Cosmetic Act pre-empts state tort action related to injuries from medical devices with FDA premarket approval. What is your view? Bradshaw: The solicitor general on behalf of the FDA filed an amicus brief with the Court arguing that the express pre-emption provision does apply to PMA-approved devices. That’s absolutely the position that I believe is correct.
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