A bipartisan bill introduced in the Senate this week aims to address the growing issue of drug shortages.
Introduced by Senators Susan Collins, R-Maine, and Tina Smith, D-Minnesota, the Mitigating Emergency Drug Shortages (MEDS) Act would give the FDA increased authority and expand manufacturing reporting requirements.
The bill was introduced the same day the FDA released the results of a task force, which spent about a year probing the causes of drug shortages as well as proposing some solutions. The report called the pharmaceutical marketplace “broken” and said that manufacturers need financial incentives to produce drugs at risk for shortage.
According to a statement from Collins’ office, the bill would:
- Allow the FDA to not only expedite the review of drug marketing applications in the event of a shortage, but also to prioritize review of supplements and abbreviated new drug applications (ANDAs) for generic drugs, as well as inspections.
- Expand manufacturer reporting requirements for active pharmaceutical ingredients to include not only the manufacturers of the finished dosage form, but also the manufacturers of a drug’s active pharmaceutical ingredients (APIs). If the bill passes, the reports would include the full disclosure of the problems resulting in shortages, information concerning the extent of the shortage, expected duration, and expected impact on distribution and availability in pharmacies.
- Require manufacturers to report contingency and redundancy plans to the FDA for drugs that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any drug used in emergency medical care or during surgery.
- Modify the FDA’s drug shortage list, expanding it to include regional shortages. In addition, listed reasons for shortages would be expanded to include shortages of particular strengths and dosage forms.
- Direct the General Accounting Office to examine the FDA’s intra-agency coordination, communication, and decision making in assessing drug shortage risks and taking corrective action.
- Require HHS and the Department of Homeland Security to conduct a risk assessment of national security threats associated with the lack of adequate domestic capacity and capability for the manufacturing and distribution of critical drugs, their APIs, and associated medical devices used for preparation or administration.
The MEDS Act is supported by Premier, the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Health-Systems Pharmacists, and the Institute for Safe Medication Practices.
There were more than 200 shortages in 2018, the organizations said, and “The MEDS Act is a thoughtful, holistic and sustainable approach to eliminating drugs shortages,” said Blair Childs, senior vice president of public affairs of Premier, in a statement.
Collins’ office said drug shortages add $230 million a year to US drug costs and $216 million a year in increased labor costs as healthcare providers scramble to find an alternative source of medication.