AMA Wire

Wednesday, July 4, 2012

This Week's News

Congress adopts bill addressing drug shortages, antibiotic development

Congress adopts bill addressing drug shortages, antibiotic development

Bipartisan legislation sent last week to President Obama for his signature would pave the way for important improvements that would help address the nation's drug shortage problems. Obama is expected to sign the bill.

While the focus of the Food and Drug Administration Safety and Innovation Act is on authorizing the fees drugmakers and medical device manufacturers pay the Federal Drug Administration (FDA), the AMA worked with Congress to strengthen other instrumental provisions in the final bill.

The bill takes steps to ease the national drug shortage crisis, thanks to an expanded number of drugs about which manufacturers will be required to provide early notification of possible shortages. The bill also provides incentives for drugmakers to develop new antibiotics to tackle the growing number of bacteria that are now resistant to most antibiotics currently available.

"National drug shortages threaten patient care and delay needed medical treatments, compromising a patient's ability to access the drugs they need when they need them," AMA President Jeremy A. Lazarus, MD, said in a statement. "The AMA is pleased this legislation expands FDA authority to avert or mitigate drug shortages and to incentivize the development of next generation antibiotics."

Other issues addressed in the bill include categorizing the chemical substances known as "bath salts" as Schedule I controlled substances and requiring a national report on the issues posed by rogue online pharmacies. The final version of the bill also omitted a provision that would unintentionally limit access to necessary pain treatment by reclassifying products containing hydrocodone as Schedule II drugs.