Can Pharma Hide Side Effects of Marketed Drugs in the U.S.?

Many believe that the pharma industry hides negative data on its drugs.

By John LaMattina

This column first appeared on Forbes.com

Most people don’t have a clue as to the vigorous requirements put on pharma by the FDA for reporting a drug’s side effects. In fact,  when I write about the pharmaceutical industry, particularly posts that support the value that the industry adds to healthcare, I will often get attacked that I am defending an evil empire. Many believe that the industry hides negative data on its drugs. The following is typical: “Side effects should be monitored and updated and told to patients and doctors. Not hidden as they are right now.”

Pharma’s reporting requirements are defined in the U.S. FDA Code of Federal Regulations (21 CFR 314.80). Essentially, a U.S. Drug Manufacturer (Marketing Authorization Holder) is required to report serious, unexpected, drug related individual case safety reports within 15 calendar days of initial receipt as well as to report any follow-up information within 15 calendar days of receipt of new information. Read the full column.
Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments