WASHINGTON – U.S. Senators Amy Klobuchar (D-MN), Susan Collins (R-ME), Tina Smith (D-MN), Lisa Murkowski (R-AK), and Elizabeth Warren’s (D-MA) bipartisan legislation to prevent and mitigate both prescription and nonprescription drug shortages passed out of the Health Education Labor and Pensions (HELP) Committee on a bipartisan vote of 17 to 3. The Drug Shortage Prevention Act would require manufacturers of over-the-counter and prescription drugs to notify the Food & Drug Administration when they are unlikely to be able to meet the demand. The legislation also requires drugmakers to provide information about their suppliers of active pharmaceutical ingredients and in-process materials to the FDA.
This legislation passed the HELP Committee as part of the Pandemic and All-Hazards Preparedness and Response Act.
“These common-sense reforms will help ensure that Americans have access to the medications they need to stay healthy,” said Klobuchar. “By requiring drug manufacturers to notify the Food & Drug Administration on circumstances that may lead to a shortage, as well as supply chain information, this legislation will help bolster efforts to address and prevent nationwide medication shortages and help ensure a more resilient medication supply. I will keep working to ensure all Americans can reliably get the medication they need, when they need it.”
“The last thing patients and health care providers should have to worry about is whether there will be an adequate supply of the lifesaving medications they rely upon,” said Senator Collins. “Our bipartisan bill will give FDA additional tools and visibility into the supply chain in order to help prevent and mitigate drug shortages. I applaud the Senate HELP Committee, on which I serve, for including key provisions of our bill in the Pandemic and All-Hazards Preparedness And Response Act that was reported out of Committee today. These meaningful, yet targeted policies will strengthen our national response to the drug shortage crisis Americans are facing.”
“We need to do everything we can to deliver high quality health care, but right now drug shortages are hurting patients, pharmacists, and physicians alike,” said Senator Smith. “I have heard directly from Minnesotans who are facing shortages of Adderall and other critical drugs, which can be life-threatening. I’m glad to be working on a fix to help address this problem. Our bill will help minimize drug shortages by improving the FDA’s responsiveness when product demand outpaces the supply. As a member of the Senate Health Committee I’ll continue working to improve drug accessibility and affordability.”
“Too many Americans are struggling to get the critical medications they need,” said Senator Warren. “With an alarming rise in drug shortages in the U.S., the Drug Shortage Prevention Act will ensure FDA has the information it needs to get ahead of shortages before they occur.”
“I’ve heard far too many stories of Alaskans facing the dangers of life-saving drug shortages. Nobody should have to wonder if the hospital will have the medication they need, or hear from their provider that they need to ration the drug they depend on. More transparency and better reporting are needed to ensure no one has to face that uncertainty. That’s why I’m supporting the Drug Shortage Prevention Act, which will enhance the FDA’s preparedness by working to avoid drug shortages,” said Senator Murkowski.
This bipartisan legislation would expand on the Preserving Access to Life-Saving Medications Act that was signed into law in 2012 as a part of the Food & Drug Administration Safety & Innovation Act of 2012.
The Drug Shortage Prevention Act has three provisions
- Requires pharmaceutical manufacturers to notify the FDA of an increase in demand, an export restriction, or other circumstance that is likely to leave a manufacturer unable to meet demand without meaningful shortfall or delay.
- Requires, at the Secretary’s discretion, manufacturers of over-the-counter and nonprescription medications (e.g., pediatric pain relievers), to notify FDA of a circumstance that is likely to lead to a meaningful shortfall or delay in supply.
- Requires drugmakers to report to FDA who their suppliers are of active pharmaceutical ingredients (APIs) and other must-have items in the manufacture and distribution of the drug (e.g., vials).
The bipartisan House companion bill is led by Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL).
Klobuchar has been a national leader in efforts to address prescription and over-the-counter drug shortages.
This past January, Klobuchar led a letter with Senator Smith urging the Department of Health & Human Services (HHS) and FDA to convene the Drug Shortage Task Force, which was created by a previous Klobuchar bill, to mitigate factors causing nationwide drug shortages.
In December, a number of key provisions authored by Smith to mitigate drug shortages, streamline the FDA approvals process, and promote domestic manufacturing were included in the 2023 Omnibus Appropriations Bill. These bipartisan provisions originated from Smith’s Modernizing Therapeutic Equivalence Rating Determination Act, Consistent Legal Evaluation and Regulation of Medical Products (CLEAR) Act, and Onshoring Essential Antibiotics Act. Additionally, the 2023 Omnibus Appropriations Bill included language from Smith's bipartisan American Made Pharmaceuticals Act to reduce dependence on foreign pharmaceutical manufacturing and boost production in the U.S.
In November 2022, Klobuchar pressured the FDA and HHS to address the critical shortfall on Amoxicillin supply and to convene the Drug Shortage Task Force to identify the cause of the shortage.
In 2021, Smith and Senator Ben Cardin (D-MD) introduced the Drug Shortages Prevention and Quality Improvement Act to address some of the root causes of drug shortages and extend additional tools the FDA can use to mitigate drug shortages.
In 2020, provisions from Smith and Senator Collins’s (R-ME) bipartisan Mitigating Emergency Drug Shortages (MEDS) Act, which improves reporting requirements of potential drug shortages and helps increase the supplies of vital drugs, were enacted into law as part of the CARES Act.
In 2012, Klobuchar and Senator Bob Casey (D-PA) led the Preserving Access to Life-Saving Medications Act, which Collins also cosponsored. This bipartisan legislation was signed into law as part of the Food & Drug Administration Safety & Innovation Act of 2012 (FDASIA). The Klobuchar law allows the FDA to require drug manufacturers to report to the FDA six months in advance if any supply or manufacturing disruption could lead to a prescription drug shortage. The law also created the Drug Shortage Prevention Task Force and requires the FDA to submit a report to Congress every year on drug shortages.
In 2022, the number of new drug shortages tracked by FDA was 49, compared to a peak of 251 new shortages during 2011 before Klobuchar’s 2012 bill was passed giving FDA more tools to prevent shortages.