Congress OKs plan to combat drug shortages

Physicians, hospitals and other health organizations largely support the final package, but more changes will be sought to the shortage early warning system.

By Jennifer Lubell — Posted July 2, 2012

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As part of what probably will be the only major piece of health care legislation to get through Congress in a heated election year, House and Senate lawmakers in late June approved a plan to mandate early warnings from drugmakers about possible shortages of crucial medications.

The final bill to reauthorize the Prescription Drug User Fee Act, which contained the shortage provisions, largely satisfied members of organized medicine. Some physician organizations, however, had been pressing Congress to adopt stricter enforcement language and include biologic drugs in the early notification system that would alert federal officials of potential shortages.

The legislation reauthorizes for five more years Food and Drug Administration user fees paid by drug and medical device companies, and it creates new user fees for FDA reviews of generic drugs and biosimilar products. Drugmakers pay the fees to the FDA in exchange for expedited reviews of new therapies. On June 20, the House approved a consensus version of the legislation by voice vote. The Senate followed on June 26 by a vote of 92-4. President Obama was expected to sign the measure into law.

The American Medical Association offered broad support for the bill’s user fees and other major provisions in the legislation, including language to establish the drug shortage early warning system. Drugmakers would be required to notify the FDA at least six months before a lifesaving drug is discontinued or if a meaningful, foreseeable disruption in the supply of that drug will occur due to a manufacturing interruption.

The AMA “commends the House and Senate for working in a bipartisan manner to develop and pass the FDA user fee bill, and appreciates that the legislation includes other provisions essential to patient access to safe and effective health care,” AMA President Jeremy A. Lazarus, MD, said in a statement. “National drug shortages threaten patient care and delay needed medical treatments, compromising a patient’s ability to access the drugs they need when they need them. The AMA is pleased this legislation expands FDA authority to avert or mitigate drug shortages.”

The AMA House of Delegates had adopted a report containing similar recommendations for a mandatory early notification system at its Annual Meeting in Chicago the week of June 18.

Delegates at the meeting asserted that the inability to obtain crucial drugs because of ongoing and recurring shortages was thwarting the ability to provide good patient care. “Drug shortages are affecting our best practices, and we consider it a patient safety issue,” said C. Alvin Head, MD, a delegate from Augusta, Ga., speaking on behalf of the American Society of Anesthesiologists.

More than 225 drugs are listed as being in short supply by the American Society of Health-System Pharmacists. Many shortage drugs are generic sterile injectables, including anesthesia and chemotherapy drugs.

Christopher Hansen, president of the American Cancer Society Cancer Action Network, hailed the bill’s establishment of an FDA task force that will work with the Dept. of Health and Human Services to create a strategic plan for preventing or mitigating drug shortages. Drug shortage problems have been “experienced firsthand by cancer patients and survivors who have been denied access to lifesaving drugs that are in short supply.”

Premier health care alliance, which represents hospitals and health systems, also praised the bill’s language addressing shortages, saying members were encouraged that the final bill will allow health systems to repackage shortage drugs into smaller doses and redistribute them to affiliate hospitals.

But the American Society of Clinical Oncology and the American Society of Hematology were among the groups that thought the final language on drug shortages fell short in a few areas. The hematology society was hoping that Congress would adopt language from the original House-passed version of the reauthorization bill, which automatically would have included biologics in the early notification system. The final legislation instead gives HHS the discretion to incorporate biologics, human plasma protein products and recombinants replacing human tissue into the warning system through the rulemaking process.

Drugs of this type are used to treat patients with blood cancers and hemophilia as well as other bleeding disorders, the hematology society said in a statement. “They are critical to the delivery of care for patients with blood disorders, and the noninclusion of these drugs puts these patients in jeopardy,” it said.

On its policy website, ASCO said it will urge HHS Secretary Kathleen Sebelius to use the rulemaking process to include biologics once the legislation is signed into law, “as they are already first-line treatments for numerous cancers and will only become more critical components to care.” The oncology society also commented on the lack of fines or some other type of enforcement mechanism in the final bill to ensure that manufacturers comply with the early warning requirement. The society said it will continue to advocate for additional legislation adding this requirement.

David Rosen, a partner and co-chair of the life sciences industry team and chair of the FDA practice at Foley & Lardner LLP in Washington, said such a penalty may not necessarily be warranted. Achieving public health and safety is the most important goal, he said. “If we have the patients’ best interests primary and central to the issue, then companies should take it upon their own responsibility that if they believe they’re not going to meet patient needs, then they should notify FDA.”

One of the final bill’s more vocal critics, advocacy group Public Citizen, said some of its provisions actually would weaken drug and medical device safety. For example, the group said, the final version unnecessarily expands the use of the accelerated drug review process, “which, among other things, relies on much smaller clinical trials to approve a wider range of new drugs.”

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What health organizations got in final drug shortage bill

House and Senate lawmakers swiftly negotiated a compromise on a reauthorization of prescription drug user fee programs and a new drug shortage warning system. The consensus bill generated widespread support from health care organizations that had asked for certain provisions to be included in the final version.

American Medical Association: The final bill includes measures to avert or mitigate drug shortages, as well as regulatory modifications to incentivize research, development and manufacture of next-generation antibiotics. It also bans synthetic drugs such as “bath salts” and addresses problems posed by “rogue” online pharmacies.
American Society of Clinical Oncology: The legislation includes generic drug user fees, which will provide the Food and Drug Administration with funding to review generic drug applications more quickly, speeding up their availability to patients.
Premier health care alliance: The measure will require the FDA to list drugs in shortage not only by their names but also by their national drug codes. It also sets up a national, uniform system for identifying medical devices.
National Assn. of Chain Drug Stores: The final bill increases requirements, inspections and oversight for domestic and foreign drug and drug ingredient manufacturing facilities. It also authorizes the FDA to destroy counterfeit or adulterated imported drug products, and increases penalties for intentional drug adulteration and counterfeiting.

Sources: AMA, ASCO, Premier health care alliance, NACDS

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