CDER Director's Mailbag: Answered Questions
May 7: I have been taking Singulair since its release and feel that I am being penalized because of a new patient use that extends exclusivity and prevents a generic version from being approved. I truly feel that FDA is more concerned with the drug companies than the people taking these medications.
FDA approved the first generic versions of Singulair on August 3, 2012 for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. For people who ... more
The success of the generic drug industry has led to more applications for new products than FDA could review in a timely manner. This increase, along with a program funding that remained relatively flat, ... more
April 12: What is FDA's policy on testing multiple investigational cancer drugs together? At the rate, combination therapies may offer the best approach to treat aggressive cancers and prevent cancer drug resistance. How is the FDA facilitating this effort, and what trials should we look at as "best in class" in this area?
Combination therapy is an important treatment method in many disease settings, including cancer. In settings where combination therapy provides significant therapeutic advantages, there is growing ... more
April 4: Understanding the need for additional funding and a Generic Drug User Fee Amendments (GDUFA) system, do you have any concern that the projected fees as currently published will cause severe financial hardship to the small to mid-size generic companies? My fear is that the larger generic companies will eventually take over the industry, drive out the small guys, and increase drug prices.
This was a concern discussed by the pharmaceutical industry and FDA during the Generic Drug User Fee Amendments negotiations meetings. FDA and organizations that represent active pharmaceutical ... more
March 11: I am a post-doctoral student in a cancer research lab. Would it be possible for me to attend an advisory committee meeting?
Absolutely! Most advisory committee meetings are open to the public. They are closed only when company trade secrets or confidential commercial information will be discussed. To find out more about ... more
We do not approve health care facilities, laboratories, or manufacturers. However, FDA does inspect product manufacturers to verify that they comply with good manufacturing practices. Owners and ... more
February 25: I have developed a unique way of combining an already marketed drug with its delivery device to prevent fatal complications. How do I get patent for this?
The FDA does not issue patents. If you want to obtain a patent to cover your device for use in the United States, you should contact the U.S. Patent and Trademark Office.
February 25: During the May 9, 2012 FDA review of tofacitinib, the advisory committee voted 8-2 to approve. Did the committee comment on the lymphoma side effects and any relationship to adverse events and higher doses?
The transcript for the meeting is posted on the FDA Internet site and can be found on the 2012 Meeting Materials, Arthritis Advisory Committee Web page. The committee’s comments about tofacitinib are included in the transcript.
You can find lists of U.S. pharmaceutical companies online. The Pharmaceutical Research and Manufacturers of America (PhRMA ) website includes a list of its member companies. Drugs.com and Medilexicon ... more
February 15: I have been trying to find a place online that lists medication currently approved for patients with arachnoiditis. My doctor won't prescribe any pain meds so I suffer every single day. Patients like me no longer have a voice and we can't get the help we need.
Arachnoiditis is caused by the inflammation of a membrane that surrounds the nerves. It is a difficult condition to treat. Usually, treatment is limited to relieving the pain. Try to find a health care professional ... more
February 5: I am confused as to why some drugs are available as both a prescription and an over-the-counter drug. Can you explain?
A medication that is marketed as both a prescription medication and an OTC medicine may contain the same active ingredient; however, the dosage strength and form, the dosing regimen or the indications ... more
January 30: Is there any indication that FDA will stop regulating my cells? I cannot afford to travel great distances to obtain stem cells treatment for my chronic obstructive pulmonary disease. If stem cells are deemed a drug when will FDA allow clinical trials?
The regulation of stem cells or cell therapy in general, does not fall under my center; that’s regulated by the Center for Biologics Evaluation and Research (CBER) in FDA. I will refer you question to CBER. ... more
January 23: When Reumofan was taken off the market FDA stated that an ingredient in the pill created ulcer-like problems. This side effect is found in a number of over-the-counter pain relievers. What is FDA doing to approve a Reumofan alternative?
The question incorrectly assumes that the Reumofan products were lawfully marketed and, subsequently, “taken off the market” because of adverse effects. Rather, in June 2012, FDA alerted the public ... more
With curdled milk or petrified cucumbers it's easy to see when your food is past its prime; it's a little trickier with medicines. During the late 1970s, FDA began requiring an expiration date on prescription ... more
January 16: When I buy a generic brand drug from Costcos or Walmart, the labels say they come from India. Are they okay to use?
Yes, they are okay to use. As with many consumer goods and other products used in the United States, a lot of medications or their active ingredients are made outside of our country. FDA works with ... more
FDA is prohibited by law from commenting on investigational drugs, proposed clinical trials in the United States, or drugs pending approval. This information is considered confidential to the ... more
January 3: When you have two drugs with the same active ingredient, why is one classified as an over-the-counter drug and the other is sometimes classified as a prescription drug?
Here’s a bit of history–the original Federal Food, Drug, and Cosmetic Act of 1938 made no clear-cut distinction between prescription and over-the-counter (OTC) drugs. That changed with the 1951 ... more