pet connection

On USA Today’s opinion page (thanks, Gail), a damning indictment of FDA’s kid-gloves treatment of those it’s regulating:

During the process that took ProHeart 6 off the market, the drug’s maker investigated and denounced a Food and Drug Administration scientist who gathered the damning data. And instead of protecting its scientist, the FDA booted her off the case and tried to have her criminally prosecuted.

It’s a disturbing tale for anyone who relies on pharmaceutical companies and the FDA to ensure that medicines for animals and humans are safe, one that raises questions about the conduct of a major corporation and its federal regulator.

Here’s the rest. The FDA sees it differently, of course. Without mentioning the earlier treatment of its whistleblower veterinarian, the Dr. Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine, counters that the process that brought the drug back onto the market is:

[...] a good example of how the FDA’s scientists tackle the toughest challenges.

ProHeart 6 is the first veterinary drug marketed under a risk minimization and restricted distribution program that allows veterinarians to weigh the risk of heartworm disease in their canine patients with the benefits of a six-month injection that maximizes protection.

About 30 FDA-regulated products for humans are marketed under similar risk management programs. Such programs help ensure that health care professionals have access to products that are safe and effective, that patients are aware of potential risks, and that the products are used properly.

Here’s the rest. What do veterinarian bloggers think? Pet Connection BFF Dr. Patty Khuly, here, and Dr. Everett Mobley, here.

I’m tempted to say I agree with the FDA. This is  ”a good example of how the FDA’s scientists tackle the toughest challenges.”

And that’s the problem.