Washington, D.C.—A new law authored by U.S. Senator Susan Collins (R-ME), the Chairman of the Aging Committee, and Senator Tina Smith (D-MN) will help increase the availability of vital drugs needed to treat or prevent a wide variety of diseases, illnesses, and conditions.
Components of the Mitigating Emergency Drug Shortages (MEDS) Act, which was supported by 14 health care organizations, was included as part of the Phase 3 coronavirus emergency response package that was signed into law on March 27, 2020.
“At a time when our health care system is overburdened by the COVID-19 pandemic, the last thing doctors, nurses, and patients should have to worry about is whether there will be an adequate supply of the lifesaving medications they need,” said Senator Collins. “Given that 13 percent of the facilities making active pharmaceutical ingredients for the U.S. market are located in China, it is important for the FDA to have greater visibility into the drug supply chain. Our legislation will help prevent disruptions and help increase the affordability and accessibility of prescription drugs.”
“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. “But in 2018—the latest full year we have data for—there were more than 200 drug shortages in the United States, and that number has continued to increase. 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 manufacture 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 include also 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 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.