You may not have noticed, but the FDA may be about to see the biggest overhaul to its powers in many years. The bill has passed both houses of Congress, and it's expected to be signed by the president. A cheat sheet to what's in store:
1) Those clinical trials that Big Pharma forgets to finish once a drug is approved? They've really got to finish them now.
2) Big Pharma doesn't get to decide what claims they make about its drugs anymore.
3) Here's the big one:
The whole thing is likely to be seen as a victory for critics of the industry, of course. But is there any way this doesn't end up being good for Big Pharma too? More transparency, tougher standards, an agency that can throw its weight around a little -- sure, there was plenty left out of this bill, but it has to be said that this must help resuscitate the public's faith in the industry.
1) Those clinical trials that Big Pharma forgets to finish once a drug is approved? They've really got to finish them now.
2) Big Pharma doesn't get to decide what claims they make about its drugs anymore.
3) Here's the big one:
One of the farthest-reaching changes may be a new requirement demanding that the drug companies list all of their clinical trials in a registry maintained by the National Institutes of Health, accessible to anyone with an Internet browser. After the studies finish, the results will also have to be posted. This will expose drug companies to new levels of scrutiny about the safety of their medicines.
The whole thing is likely to be seen as a victory for critics of the industry, of course. But is there any way this doesn't end up being good for Big Pharma too? More transparency, tougher standards, an agency that can throw its weight around a little -- sure, there was plenty left out of this bill, but it has to be said that this must help resuscitate the public's faith in the industry.
