« "You Guys Don’t Do Innovation. The iPad. That’s Innovative" |
| Exelixis Fights City Hall, and City Hall Looks Like Winning »
November 1, 2011
President Obama Orders the FDA to. . .Do What, Exactly?
Headlines of the "Obama Orders FDA to Take Action on Drug Shortages" were all over the news yesterday. But anyone who actually knows the industry could be forgiven for wondering what was going on.
That's because the drug shortage problem is not something that can be solved by fiat. There are a number of factors that got us all into this fix: two big ones are changes in Medicare billing for generic cancer drugs, and manufacturing problems with overseas suppliers. (A low-margin business gives you even more incentive to source the bargain-basement options). None of these things can be fixed overnight.
And when you look at the executive order itself, you find that there's not much there. It directs FDA to expedite reviews of new suppliers and new manufacturing sites, but aren't they doing that already? And it also tells the agency to send out letters to all the companies, reminding them to remind the FDA about potential shortages, which is clearly the kind of decisive step this crisis has been waiting for. Oh, and it also calls for determining whether any of the shortages have led to "price gouging". Can't have the price of something going up just because there's a shortage - that's just basic economics, right?
So call me cynical, or call me someone who just hasn't been that impressed with Obama. (Note: the Republicans have not been covering themselves in glory, either, as far as I can see). But this whole announcement seems to be just a public relations game, made to provide a line for a speech. "Congress wouldn't take action, so I issued an Executive Order for the FDA to. . ." But during the campaign, that sentence won't end the way it should: ". . .for the FDA to do what it's already doing! Yes! And send out some letters, too!"
+ TrackBacks (0) | Category: Regulatory Affairs
POST A COMMENT
- RELATED ENTRIES
- Adoptive T-Cell Therapy for Cancer: The Short Version
- How Much Is Wrong?
- The 2013 Drug Approvals: Not So Great?
- Positive Rules and Negative Ones
- Prices Rising - Every Year, Every Drug?
- Easy Aziridines
- Back Blogging (Bonus Biographical Begging)
- It Just So Happens That I Have A Conference Right Here