Congress approves plan to stop drug shortages
The final bill to reauthorize the Prescription Drug User Fee Act contained the shortage provisions and mostly satisfied members of organized medicine. The legislation reauthorizes user fees paid by drug and medical device companies to the Food and Drug Administration in exchange for expedited reviews of new therapeutics.
President Obama is expected to sign the bill into law after its passage by the House on June 20 and the Senate on June 26.
The drug shortage early warning system would require drug makers to notify the FDA at least six months prior to the discontinuance or foreseeable disruption of a lifesaving drug.
"(The American Medical Association) commends the House and Senate for working in a bipartisan manner to develop and pass the FDA user fee bill, and appreciates that the legislation includes other provisions essential to patient access to safe and effective health care," Jeremy A. Lazarus, the president of the AMA, said. "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. The AMA is pleased this legislation expands FDA authority to avert or mitigate drug shortages."
The House of Delegates of the AMA recommended the mandatory early notification system at its annual meeting in Chicago on the week at June 18. The inability to obtain necessary drugs as a result of ongoing and recurring shortage has hindered the ability to provide good care to patients.
Biologics were not outright included in the early notification system portion of the bill. The Department of Health and Human Services has the discretion to incorporate biologics, recombinants replacing human tissue and human plasma protein products through the rule-making process.
"(Drugs of this type) are critical to the delivery of care for patients with blood disorders, and the non-inclusion of these drugs puts these patients in jeopardy," the American Society of Clinical Oncology and the American Society of Hematology said.