A bill requiring biopharm manufacturers to give the FDA early notification of potential drug shortages has been introduced to the US Senate.
Drug shortages have become a high profile issue, in the US and overseas, and the US Food and Drug Administration (FDA) lists more than 50 treatment types with restricted supply . Last week the UK outlined plans to tackle the issue and US Senators have now detailed their proposals.
“As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA and health care providers so patients don’t lose access to the medications they depend on”, said Senator Amy Klobuchar, who sponsored the bill.
The Preserving Access to Life-Saving Medications Act would require prescription manufacturers to give the FDA early notification of incidents likely to result in a shortage. Incidents to be reported to the FDA include changes to raw material supplies, manufacturing adjustments and mergers.
Adoption of the bill would also place requirements on the FDA. Agency responsibilities include providing up-to-date public notifications of shortage situations and actions it will take to address the problem.
Klobuchar has titled the proposal “A bill to amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages”. It was introduced to the Senate on Monday, read twice and then referred to committee.
Senator Robert Casey co-sponsored the bill. Klobuchar says the bill is backed by numerous groups, including: the American Hospital Association; the Institute for Safe Medication Practices; the American Society of Clinical Oncologists; and the American Society of Anesthesiologists.
Anaesthesiology and oncology are two of the sectors reported to suffer from drug shortages. The situation has escalated in recent years and “right now it's as bad as it's ever been", Bona Benjamin of the American Society of Health-System Pharmacists (ASHP) told USA Today.
Data collated by ASHP shows the rise in drug shortages. In 2006 there were around 50 drugs in short supply but by 2009 this figure had trebled. The number dipped slightly in 2010 but was still close to 150.
However, the figure for 2010 hides a surge in shortages of sterile injectables. These products, some of which are critical drugs, accounted for 77 per cent of medication shortages in 2010.
ASHP says this was mainly due to product quality problems but discontinuations, delays and active pharmaceutical ingredient (API) issues also contributed to shortages of sterile products.
The bill has been welcomed by ASHP. Henri Manasse, Jr, CEO of ASHP, said: “We are pleased to see a legislative proposal offered to address this critical issue and will advocate strongly for its passage.”