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CDER Director's Mailbag: Answered Questions -- 2012

CDER Director's Mailbag


December 11: Do you believe that the drugs FDA approves are really safe? I don't totally agree with that.

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  ... more

November 28: I have a question about a Risk Evaluation and Mitigation Strategy. At what point is the drug company notified that a REMS is required?

FDA can require a REMS before a drug is approved if we determine that a REMS is necessary to ensure that the benefits of the drug outweigh the risk. In addition, FDA can require a REMS after a drug is  ... more

October 29: We are developing an anti-cancer drug. We have reports and studies related to the drug. What are the steps to obtain FDA approval?

FDA’s Pre-Investigational New Drug Application Consultation Program is designed to facilitate and foster early communications between the Agency and potential sponsors of new therapeutics. Advice can be  ... more

October 19: My husband has been on VESIcare for some time but our insurance has not labeled it as a tier 3 medicine. This means that we pay approximately $265 per month, which is a financial burden to me and my family. I wanted to know if VESIcare will be available in a generic form sometime soon.

While there are currently no generic VESIcare products available, companies can begin manufacturing generic versions of a drug after its patent expires and FDA approval is granted. However, new patents ... more

October 11: What is in generic Plavix that makes me break out in whelps?

A generic drug is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many ... more

October 3: Are there any plans to provide on the FDA website drug information for all approved drug products similar to what is available on the European Medicines Agency website?

Actually, that information is already available in the Drugs@FDA database. You can use Drugs@FDA to find: labels for drug products; if there are generic versions of a drug available; therapeutically equivalent ... more

October 3: Can you explain what is meant by tentative approval?

If a generic drug product application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product, FDA issues  a tentative approval letter to ... more

September 26: If I want to work in your office or at the FDA in general, where should I look?

First, thank you for considering FDA as a place of employment. The Federal government is always competing for the best and the brightest, and we hope more folks join the team. You can apply to FDA... more

September 26: If I buy a product from Walmart that does not work, I can return it and get my money back. Why is it if I buy a drug that does not work, I cannot return it to the store?

If your drug does not work, you should talk to your doctor or pharmacist to ensure that you are taking it correctly or that there is not an interaction with a food or another drug that is affecting how ... more

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

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