PSM2012: FDA Commissioner Margaret Hamburg’s Keynote Speech

Dr. Margaret Hamburg, FDA Commissioner, addressed the Interchange in her keynote speech.

Hamburg said that "We need to work together to stay ahead of the many avenues that criminals are finding that are putting the health and safety of American citizen's at risk."

Calling them 21st Century snake oil peddlers, Hamburg said that FDA has a number of new tools to help fight them.

FDASIA improves the abilities of the FDA to have better access to manufacturing records, and greater ability to curb importation of medication that did not meet FDA standards. It also provides for enhanced criminal penalties and extra-territorial prosecutions.

Globalization is the largest challenge of the FDA today. Though many counterfeit medications come in from overseas, Hamburg pointed out that there are many FDA approved facilities overseas that provide medications to the United States.

Hamburg
mentioned both heparin and insulin adulteration cases that impacted American
patients' detrimentally. Afterwards, FDA ranked medications for their
likelihood to be adulterated for economic profit to keep a closer watch on
those medications.  

Hamburg then mentioned that Altuzan, a not FDA approved medication had been found in the US, but then the medication was actually counterfeit and contained no active ingredient. Later in the year, FDA notified consumers that counterfeit Adderall was found on the internet containing tramadol instead.  

Hamburg discussed their new screening device, CD3, which allows for real-time onsite comparison with suspected counterfeit drugs. 

FDA needs
a more proactive approach to combating counterfeits by helping consumers
understanding the problem and how their choices impact their health, especially
in the use of illicit online pharmacies, said Hamburg.  

FDA developed the Be Safe Rx campaign to education consumers to make informed and safe choices in their medications. While purchasing online from real pharmacies, and using mail order pharmacies, are legal and safe things to do, as long as they are not purchasing from fake onine pharmacies that can be located overseas, said Hamburg. 

Hamburg encouraged doctors to be aware of counterfeit medications and to warn patients to avoid fake online pharmacies. Doctors should be aware of the symptoms of counterfeit medication ingestion.  

FDA and PSM need to continue to work together to education patients, and protect patients, putting health and safety of patients first.