“It’s too early to know if this will work,” said Craig Coopersmith, MD, of the Emory University School of Medicine in Atlanta, Georgia, speaking about the FDA plan to hasten generic drug approvals. “I am, however, highly encouraged that a concerted effort is being put into this. In the best-case scenario, this effort will bring down costs and reduce drug shortages.”

“The potential downside of fast-tracking is that a rush towards approval will result in a less thorough review,” Dr Coopersmith said. “Having said that, the concept of trying to more rapidly get effective drugs to our patients has significant appeal.”

Continue Reading

So far in 2017, there have been 96 full or tentative ANDA approvals announced. But that has not yet translated to fewer drug shortages or lower costs, Dr Coopersmith said.

“Anecdotally, drug shortages are very much the medical equivalent of whack-a-mole,” he said. “As soon as one goes away, another one crops up.”

Michael Rie, MD, of the University of Kentucky in Lexington, is less optimistic that the FDA can curb drug prices.

“I doubt it’s going to do any significant good,” Dr Rie said. “First of all, it’s fine that they want to hasten approvals. But…who will want to come forward to do this on the generic side unless [that person] has some way to know that they will be adequately recompensed? That’s been a major problem with generics.”

Nor is FDA approval of new generics a panacea for prices or drug shortages, argued Dr Rie, who is a member of Physicians Against Drug Shortages.

“We have shortages of life-saving drugs that are approved,” he noted. “The [FDA] announcement is not a bad thing. It’s just irrelevant, in terms of the availability of generic drugs.”

References

  1. FDA tackles drug competition to improve patient access: agency take important steps under new Drug Competition Action Plan [news release]. Silver Spring, MD: US Food and Drug Administration; June 27, 2017. https://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ ucm564725.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed July 2017.
  2. List of off-patent, off-exclusivity drugs without an approved generic. US Food and Drug Administration website. https://www.fda.gov/downloads/Drugs /ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM564441.pdf. Accessed July 2017.
  3. Generic competition and drug prices. US Food and Drug Administration website.  https://www.fda.gov/aboutfda/ centersoffices/officeofmedicalproductsandtobacco/cder/ucm129385.htm. Accessed July 2017.  
  4. Pollack A. Drug goes from $13.50 a tablet to $750, overnight. The New York Times website. https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html. Published September 20, 2015. Accessed July 2017.
  5. Gottlieb S. FDA working to lift barriers to generic drug competition. FDA voice. https://blogs.fda.gov/fdavoice/index.php/2017/06/fda-working-to-lift-barriers-to-generic-drug-competition/. Published June 21, 2017. Accessed July 2017.

Topics:

Bladder Cancer Bone Cancer Brain Cancer Breast Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Endocrine Cancer Gastrointestinal Cancer General Oncology Genitourinary Cancer Gynecologic Cancers Head and Neck Cancer Hematologic Cancers Lung Cancer Lymphoma Multiple Myeloma Prostate Cancer Renal Cell Carcinoma Sarcoma Skin Cancer