Ch-ch-changes


We have a new party in charge of the houses, and many have anticipated that this would bring changes in the way we develop and market drugs. And the potential is there. Eye on FDA summarizes new legislation.

Quick thoughts:

  • Kennedy-Enzi – yes, the FDA needs greater authority for post-marketing enforcement, and I’m glad to see it on the table. The “other things” might be worrisome, given this is a Kennedy bill.
  • Fair Prescription Drug Competition Act – not sure what impact this is going to have, except having a company have the 180 day exclusivity for a generic of its own branded product. That could be a big deal, keeping an effective 6 month patent extension. Other competing bills may make this one obsolete.
  • Stem Cell Research – I’m glad this one is passing.
  • Drug Expiration Date Study – I’m glad this one is passing. I don’t like the way we calculate shelf life right now. It’s what I call “voodoo statistics.”
  • Pharmaceutical Market Access and Drug Safety Act – drug reimportation. I think this one will make people feel good if it passes, but in the long run I’m not sure how much of an impact this one is going to make.
  • Medicare Prescription Drug Price Negotiation Act – probably a good thing for seniors. What remains to be seen is whether this is going to squeeze drug R&D. Looks like superfluous drug rep positions are going to be cut first, so maybe not.
  • RU-486 Suspension and Review Act – RU kidding me? A bunch of politics taking precedence over science and ethics is par for the course for this administration. I doubt it’s going to pass, either.
  • Counterfeit Drug Prevention Act – counterfeiting is getting to be a problem. Dirty labs, herbal medicines cut with non-quality-assured drugs, and similar issues are getting worse. Hopefully this will help some.
  • Preserving Medicare for All – gotta read this one first before commenting.
  • Generics First Act – you mean this is not already the case?
  • Cloned Food Labeling Act – Probably not a bad idea.
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One Response

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