FDA Announces a Drug Approval with a Press Release

On Friday, October 10, the FDA issued a press release about a new product approval.  The approval is called Rapaflo (silodosin) capsules and it is indicated for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.  The sponsoring company, Watson Pharmaceuticals, also issued a press release about the approval of the product.  (As a side note, I’m also happy to report that the company press releases go out by RSS feed).

It may not strike many as notable that the FDA would issue a press release about a product approval, but the truth is, the agency, more  often than not, does not issue a press release about a product approval.  That is generally left to the company.  Still, almost every company WANTS the FDA to issue a press release about approval.  Therefore, inquiries to the FDA revealed a policy of sorts about the matter:

  • It would probably be a product that is a New Molecular Entity (NME);
  • It would probably be a product that is involved in the FDA’s (moribund) Critical Path Initiative
  • It would represent a breakthrough compound or be a first-in-class that represented progress in treating an unmet need or offer new treatment in a category where there was no treatment.
  • It would be a product that would present some significant safety concern that the agency would want to draw particular attention to, or the administration of the product or its use required particular attention.

Frankly, the product in question doesn’t meet any of these criteria.  While the company’s press release does characterize BPH as the most common reason that patients visit a urologist, there are other treatments for BPH.  It is a novel product, but other than that, it would be hard to see why the FDA would issue a press release. 

This may not seem like a big deal, and in many ways, it isn’t.  But the FDA appears to have changed the game on when it is going to issue a press release announcing an approval.  Is it now going to be for every compound that is first-in-class?  If so, they should make the criteria clear.  If not, everyone is going to demand a press release upon approval from the agency.  It is fine if the agency wants to do that, but if not, now they have yet another problem on their hands.

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