Bill to Help Prevent Drug Shortages Introduced by Senators Collins, Smith

In 2018, there were more than 200 drug shortages in the U.S., and that number has continued to increase this year

Washington, D.C.—U.S. Senator Susan Collins (R-ME), the Chairman of the Aging Committee, and Senator Tina Smith (D-MN) introduced the Mitigating Emergency Drug Shortages (MEDS) Act, legislation that would help increase the supplies of vital drugs needed to treat or prevent a wide variety of diseases, illnesses, and conditions. 

 

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.

 

“I often hear from patients, pharmacists, and physicians who find themselves caught in the middle of a drug shortage, with very little certainty of when the problem might be resolved,” said Senator Collins.  “Physicians and hospitals try their best to manage these shortages behind the scenes but are understandably frustrated.  Increasing the affordability and accessibility of prescription drugs is one of my top priorities, and I urge my colleagues to join Senator Smith and me in combatting this stubborn problem.”

 

“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’m glad to be working with Sen. Collins on a bipartisan effort to address this problem. Our bill will help patients live healthier lives, and cut down drug costs. As a member of the Senate Health Committee I’ll continue working to improve drug accessibility and affordability.”

 

Senators Collins and Smith have been contacted by numerous constituents who have been affected by this persistent issue.  For instance, a kidney and bladder cancer patient recently called Senator Collins’ Portland office about a lack of BCG.  He received several treatments, went into remission, and then was declined additional preventive treatments that his doctor recommended due to this shortage. 

 

Specifically, the MEDS Act would:

 

·         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.

 

·         Contingency and Redundancy Planning. Requires manufacturers to report contingency and 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.

 

·         Modifications to the drug shortage list maintained by FDA. The information contained in drug shortage lists required to be maintained by FDA would be expanded to include regional shortages.  Listed reasons for shortages would be expanded to include shortages of particular strengths and dosage forms.

 

·         GAO Report on Intra-agency Coordination. GAO will produce a report examining the FDA’s intra-agency coordination, communication, and decision-making in assessing drug shortage risks and taking corrective action.

 

·         National security risks of shortages. Requires the Department of Health and Human Services 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 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.  In a joint letter endorsing the bill, the organizations wrote:

 

“Our organizations, which have worked collaboratively to identify policy solutions to prevent drug shortages since 2010, believe that MEDS Act is a significant step in addressing the risk drug shortages present to patients, physicians and hospitals.  Serious shortages of critical drugs have become the norm for our nation’s healthcare system.  Our organizations applaud [Senator Collins and Senator Smith] for introducing this important legislation, and we look forward to working with [them] to move the bill forward.”

 

The MEDS Act is also supported by Premier, America's Essential Hospitals (AEH), American Society for Parenteral and Enteral Nutrition (ASPEN), and the Federation of American Hospitals (FAH), who wrote:

 

“The MEDS Act builds upon the prior work of Congress to provide additional authority to the FDA to help mitigate drug shortages and develop market-based incentives to help ensure a stable supply of medications critical for patient care... We applaud [Senators Collins and Smith’s] bipartisan commitment to addressing drug shortages and decreasing healthcare costs while improving patient outcomes.”