The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down.
Yesterday, the FDA's Transparency Task Force -- an oxymoron in any other era -- outlined a set of 21 steps the agency can take to make sure the public knows when, how, and why the agency makes the decisions it does. Some of the proposals aren't useful for investors; I doubt you care about transparency on the "outcome of the filer evaluation for importers or third parties working on behalf of importers." I certainly don't.
But others are clear wins for investors if they're implemented. The proposal includes disclosing:
- Inspection reports from plants.
- Refuse-to-file letters when companies turn in incomplete marketing applications.
- Complete response letters, which are doled out when the agency rejects a drug.
That last one could be a really big win for investors evaluating a drugmaker after the FDA sends it back to the drawing board.
When large drug companies -- I'm looking at you Johnson & Johnson (NYSE: JNJ), Pfizer (NYSE: PFE), and Merck (NYSE: MRK)! -- receive complete response letters, they often disclose nothing more than the fact that they got the letter. The safe-harbor statement in the press release is oftentimes longer than the terse announcement of the FDA's decision.
Smaller drug companies -- Amylin Pharmaceuticals (Nasdaq: AMLN) and InterMune (Nasdaq: ITMN) come to mind as recent examples -- usually hold conference calls to let investors know how they plan to proceed, but investors are still left at the mercy of the companies. They control what's disclosed and put their own spin on the information.
Companies argue that there are competitive advantages to keeping the information a secret, and they might be right; letting competitors know what the FDA wants could help the competitors. But it'll be a level playing field because they will all benefit from other companies' disclosures. Investors can only hope companies don't fight the measures.
The FDA is accepting public comments on the proposal through July 20. Sure, "too secret to disclose" doesn't have the same ring as "too big to fail," but I hope you'll join me in telling the FDA it's time to end the secrecy. If you don't want to comment directly to the government, leave your comment below, and I'll include your thoughts in my own comment to the FDA.
