A new law, introduced by Senators Amy Klobuchar (D-Minnesota) and Bob Casey (D-Pennsylvania), will require prescription drug manufacturers to give the US Food and Drug Administration (FDA) early warning of anything that will likely result in a drug shortage.
A new law, introduced by Senators Amy Klobuchar (D-Minnesota) and Bob Casey (D-Pennsylvania), will require prescription drug manufacturers to give the US Food and Drug Administration (FDA) early warning of anything that will likely result in a drug shortage, including things like changes in the availability of raw material, lack of manufacturing capability, or mergers and acquisitions that could affect production.
The legislation will give both the FDA and healthcare providers "more advanced notice of shortages so we can better anticipate and manage them," ASCO president-elect Michael Link, MD, said in a statement.”The oncology community is continuing to experience "severe and worsening shortages of many critical drug therapies, which disrupt important medication regimens and may threaten patients' health.”
Among the cancer drugs in short supply are carboplatin, cisplatin, doxorubicin, etoposide, leucovorin, nitrogen mustard, and vincristine.
"This is the most difficult problem here - [there are] drugs that are well-known and well established as critical components of standards of care, and [we] know from past trials that not having that drug will result in inferior outcomes," Dr. Link pointed out.
This legislation will enable pharmacists and physicians to prepare in advance for these drug shortages so that patients suffer less: “Currently, [patients] are often the last to know when an essential drug is no longer available, and "that's not right," said Amy Klobuchar in a statement to the press.
The American Society of Clinical Oncology (ASCO) and the American Society of Health System Pharmacists, have already publicly endorsed the new legislation.