MHA's Executive Briefing

Senate sends drug shortages bill to president

The U.S. Senate on June 26 voted 92-4 to approve the Food and Drug Administration Safety and Innovation Act, which includes American Hospital Association-supported provisions to help alleviate critical drug shortages. The legislation now goes to the president, who is expected to sign it into law.

The bill requires drug makers to report production interruptions and discontinuations to the FDA in advance; codifies FDA’s authority to speed approval of applications to make drugs in short supply; lifts caps on narcotic ingredients to ensure sufficient supply for anesthesia, pain management and other critical uses; and improves communications with providers and patients about the reason for potential drug shortages and how long they may last. The legislation also creates a user fee program that will help speed FDA approval of generic drugs, and allows hospitals within health systems to conserve their inventory of shortage drugs by sharing repackaged drugs.

“This bill is a concrete step in the right direction in addressing the growing number of drug shortages, which affect hospitals’ ability to provide patient care,” said AHA President and CEO Rich Umbdenstock. “In order to provide every patient with the right care, given at the right time, in the right setting, it is important that hospitals have access to the right drugs.”

AHA, others share recommendations on drug shortage bill with Congress

The American Hospital Association and 19 other organizations representing clinicians, hospitals and patient advocacy groups on June 8 sent House and Senate committees their recommendations for merging their respective versions of the Food and Drug Safety and Innovation Act (S. 3187/ H.R. 5651). “In particular, we strongly support the early notification requirements listed in both versions of the bill and given FDA’s track record of success with early notification (195 shortages avoided in 2011), we believe this notification is an essential component to help alleviate shortages,” the letter states.

Among other recommendations, the groups urged conferees “to ensure that drugs and biologics are included within the early notification requirements as well as in the other [drug shortage] provisions…and are broadly defined to cover complex and critical uses.”

Legislation to help ease drug shortages moves to conference

The U.S. House of Representatives on May 30 voted 387-5 to approve American Hospital Association-supported legislation that would reauthorize the Prescription Drug User Fee Act and help alleviate critical drug shortages. The Food and Drug Administration Reform Act (H.R. 5651) would authorize a new user fee program to speed approval of generic drugs; require drug makers to report drug discontinuations and supply interruptions to the FDA; expand FDA reporting on drug shortages; expedite applications to manufacture shortage drugs; and lift caps set by the Drug Enforcement Administration on narcotic ingredients to ensure sufficient supply for anesthesia, pain management and other critical uses.

The bill must now be reconciled with a similar measure in the Senate (S. 3187). “The AHA appreciates Congress’ hard work and dedication in tackling this critical health care issue and looks forward to swift adoption of a final legislative package,” said AHA President and CEO Rich Umbdenstock.

He said hospitals “are committed to providing every patient with the right care; given at the right time, in the right setting. The right drug is an essential element in that equation.”

Senate approves drug shortages legislation

The U.S. Senate on May 24 voted 96-1 to approve the Food and Drug Administration Safety and Innovation Act, which includes American Hospital Association-supported provisions to help alleviate critical drug shortages. The bill reauthorizes the law permitting FDA to collect user fees from makers of prescription drugs and medical devices, and allows the agency to begin collecting user fees for generic drugs.

The White House has said it "strongly supports" the legislation, which must be reconciled with a similar measure in the House.

 

Congress urged to keep drug shortages provision in PDUFA

A new ad by the American Hospital Association, American Society of Health-System Pharmacists, Institute for Safe Medication Practices, and American Society of Clinical Oncology urges Congress to “keep the drug shortages provisions” in the Prescription Drug User Fee Act. “It’s the best prescription for fighting drug shortages in America,” the print and online ad appearing May 17 in Politico states. “Drug shortages can adversely affect patients’ drug therapy, compromise medical procedures, result in medication errors, or worse…Reauthorize PDUFA so we can make sure patients continue to get the medication they need.”

The provisions strengthen requirements that drug makers report production interruptions and discontinuations to the FDA and give the agency other authority to prevent shortages and better communicate with stakeholders. The White House said it “strongly supports” passage of the legislation.

 

Committee sends drug shortage bill to full House

The House Energy and Commerce Committee on May 10 unanimously approved American Hospital Association-supported legislation that would reauthorize the Prescription Drug User Fee Act and help alleviate critical drug shortages. The Food and Drug Administration Reform Act (H.R. 5651) would authorize a new user fee program to speed approval of generic drugs; require drug makers to report drug discontinuations and supply interruptions to the FDA; expand FDA reporting on drug shortages; expedite applications to manufacture shortage drugs; and speed Drug Enforcement Agency review of requests to increase controlled substance drug quotas.

The bill also includes a section easing requirements for hospitals repackaging shortage drugs. The Senate Health, Education, Labor and Pensions Committee recently approved similar, AHA-supported legislation (S. 2516).

The full House and Senate are expected to approve a reconciled bill before the current law expires Sept. 30.

Drug shortage legislation progresses in House

The House Energy and Commerce Health Subcommittee on May 8 sent the full committee American Hospital Association-supported legislation to reauthorize user fee programs for makers of prescription drugs, which includes provisions to help alleviate critical drug shortages. The Prescription Drug User Fee Act would authorize a new user fee program for generic drugs; require drug makers to report discontinuations and interruptions in drug supplies to the Food and Drug Administration; expand FDA reporting on drug shortages; expedite applications to manufacture shortage drugs; and speed Drug Enforcement Agency review of requests to increase controlled substance drug quotas.

The full committee will mark up the legislation May 10. The Senate Health, Education, Labor and Pensions Committee approved a similar AHA-supported bill last month.

The full House and Senate are expected to approve and then reconcile their respective bills before the current law expires July 31.

Senate HELP committee approves drug shortages legislation

The Senate Health, Education, Labor and Pensions Committee on April 25 overwhelmingly approved the Food and Drug Administration Safety and Innovation Act, which includes American Hospital Association-supported provisions to help alleviate critical drug shortages. Sen. Bernie Sanders (I-VT) was the sole dissenter. The bill reauthorizes the law permitting FDA to collect user fees from makers of prescription drugs and medical devices, and allows the agency to begin collecting user fees for generic drugs.

In a letter on April 24, AHA and 14 other organizations representing clinicians, hospitals and patient advocacy groups voiced support for the drug shortage provisions, which strengthen requirements that drug makers report production interruptions and discontinuations to the FDA and give the agency other authority to prevent shortages and better communicate with stakeholders. “We remain hopeful that we can continue to work with the committee to address the lingering issues of Drug Enforcement Administration quotas, effective enforcement of the early notification requirement, and ensuring FDA has the resources it needs to maintain the supply of safe, effective medications that our patients rely on,” the groups said.

The House Energy and Commerce Health Subcommittee plans to mark up its version of the user fee reauthorization bill on May 8.

AHA calls Senate drug shortage proposal ‘significant first step’

The American Hospital Association on April 10 called a bipartisan Senate proposal for addressing prescription drug shortages as part of user fee legislation “a significant first step toward ensuring that patients have access to the medications they need.” In comments on the proposal submitted to the Senate Health, Education, Labor and Pensions Committee, AHA recommends adding civil monetary penalties or some other type of enforcement mechanism to ensure compliance, involving stakeholders in the task force proposed to mitigate and prevent drug shortages, and requiring the Food and Drug Administration and Drug Enforcement Administration to develop quotas for makers of controlled drugs.

Developed by a bipartisan working group of 18 senators, the legislative proposal would require most makers of life-saving drugs to notify the Department of Health and Human Services at least six months before discontinuances and interruptions that could lead to disruptions in U.S. supplies. HHS could expedite the review of new drug applications and inspection of new facilities when shortages are anticipated; would maintain a record of drug shortages and actions taken to mitigate or prevent them, and study and report to Congress on drug pricing practices.

The agency also could propose to apply the law’s requirements to biological products.

Hospital leaders urge Congress to address record drug shortages

Relieving and minimizing avoidable drug shortages requires both short-term interventions and longer-term permanent solutions, a hospital executive told the House Energy and Commerce Health Subcommittee Sept. 23 at a hearing on the nation’s growing drug shortages. “First, we recommend the bipartisan legislation currently in both houses of Congress requiring drug manufacturers to report potential or existing production problems to the FDA,” said Rich Paoletti, a pharmacist and vice president of operations at Lancaster (PA) General Health.

He also called for further collaboration between the FDA and manufacturers to establish evidence-based allocation plans for critical drug therapies, and exploration of incentive programs to encourage drug makers to stay in, re-enter or enter the market for critical drugs in short supply. Other witnesses at today’s hearing included Kevin Colgan, corporate director of pharmacy at Rush University Medical Center in Chicago, who voiced support for similar actions.

The American Hospital Association recently urged the Senate Health, Education, Labor, and Pensions Committee to support similar remedies.