WASHINGTON, D.C. [04/08/20]— U.S. Senator Tina Smith (D-Minn.)—a member of the Senate Health Committee—says that measures from her bipartisan bill to prevent drug shortages were enacted into law as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
The measures from Sen. Smith’s Mitigating Emergency Drug Shortages (MEDS) Act, which she introduced with Republican U.S. Senator Susan Collins of Maine, will improve reporting requirements of potential drug shortages and help increase the supplies of vital drugs needed to treat or prevent a wide variety of diseases, illnesses, and conditions.
“As we find ourselves amid the coronavirus pandemic, it’s critical that health care workers have access to the drugs they need to treat patients,” said Senator Smith. “These bipartisan measures will help mitigate this problem by prioritizing the review of drug applications and inspections in the event of a drug shortage, as well as improving manufacturer reporting and planning requirements. I’m glad that Congress passed these measures into law, and hope that they help health care workers and patients.”
Drug shortages can have severe health consequences for patients by delaying or even cancelling procedures until medication becomes available. They also add $230 million a year to U.S. drug costs and $216 million a year in increased labor costs since medical professionals must spend time identifying an alternative source of medication.
Portions of the MEDS Act included in the CARES Act include:
- Prioritize review of drug applications and inspections. In the event of a shortage, FDA is permitted to not only expedite the review of drug marketing applications, but to prioritize review of supplements and abbreviated new drug applications (ANDAs) for generic drugs as well as inspections.
- Manufacturer reporting requirements for active pharmaceutical ingredients. Reporting of an interruption or discontinuance of a drug is expanded from manufacturers of the finished dosage form to also include manufacturers of a drug’s active pharmaceutical ingredients (APIs). Reports are expanded to additional categories: full disclosure of the problems resulting in the shortage, information concerning the extent of the shortage, its expected duration, and expected impact on distribution and availability in pharmacies.
- Manufacturer planning requirements. Requires manufacturers to maintain and report risk management plans, including redundancy plans, to 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 such drug used in emergency medical care or during surgery.