CDER Director's Mailbag: Answered Questions

2012
 

September 12: Why did it take Lipitor going off patent for the FDA to add a "memory problems" warning to statins?  Where are Phase IV studies on statins?

FDA has been investigating reports of cognitive impairment or memory issues from statin use for several years. The Agency has reviewed databases that record reports of bad reactions to drugs ... more
 

August 28: Can you tell us about the FDA's position on biosimilars?

Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and ... more

 

August 15: I've noticed a run of recalls on different oral hormonal contraceptives due to packaging errors. Does the FDA have any information regarding why this is happening?

Multiple lots of birth control pills have been voluntarily recalled by manufacturers, some as the result of packaging errors. These recalls were primarily conducted to minimize the impact on patients. Users  ... more

 

June 6: If FDA’s role is to ensure safe drugs, why are so many drugs recalled or have problems?

Everybody has to be aware that the premarket testing of drugs does not detect all the problems that can occur with a drug. It just can't. This fact is important for everyone who uses, dispenses, or ... more

 

June 6: Once a drug is approved by FDA, it means the product is perfectly safe?

No drug product is perfectly safe. Every single drug that affects the body will have some side effects. During the review process, FDA considers both the benefits and risks of all medications submitted for  ... more