Drug Shortage Legislation Gains Momentum With Bipartisan House Bill
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Momentum is increasing for efforts to require manufacturers to give advance warning of a drug shortage with legislation now filed in both houses of Congress. The House version likely improved the cause by adding more specificity and extending the reach of the potential regulations. Reps. Tom Rooney, R-Fla., and Diana DeGette, D-Colo., introduced it June 21 with bipartisan support. But the new bill also underscores that there is still substantial policy work to be done and issues to be resolved, especially on the key areas of difference with the Senate bill introduced by Sens. Amy Klobuchar, D-Minn., and Robert Casey, D-Pa., in February.
The House bill extended the reach to biologics after the Senate version only included prescription drugs. It also included clearer descriptions of the circumstances that would trigger an FDA notification. The House and Senate version both require manufacturers to notify FDA at least six months before they plan to stop making a drug temporarily or permanently. In cases of unplanned interruptions, notice of at least six months or as earliest as practicable is required. But the House bill also says notice must be given when a company becomes aware of the problem or “becomes aware that such interruption may result in the total supply of the drug manufactured not meeting average historic demand.” Average historic demand was defined as a manufacturer’s average monthly sales volume of the affected drug in the last calendar year. The Senate bill only defines a shortage as not meeting the current demand “at the user level.” Joseph Hill, director of federal legislative affairs for the American Society of Health System Pharmacists, said the measure was intended to clarify the metric described in the Senate bill so it will not require a manufacturer to know the total supply of a drug, especially if there are multiple players in the market. The House provision, while seemingly well-intentioned, could dramatically increase the number of required shortage or interruption reports industry would have to send to FDA. That is by design, but requiring reports for routine manufacturing adjustments affecting supplies in addition to legitimate shortages could be an unintended consequence. Hill said in an interview the metric is not intended to be overly burdensome. “I think we do want to prevent against reporting everything and just try to get at what’s meaningful here and what would actually impact the manufacturer’s ability to produce a product,” he said. ASHP: PDUFA Is Too Late For Passage Michael Mahaffey, a spokesman for Rooney, said House and Senate staff members have not met to talk about combining the two bills. ASHP also continues to work with House and Senate staffers in an attempt to reach a consensus that potentially could avoid the need for a committee hearing. It also is possible that drug shortage provisions could be included into next year's legislation reauthorizing the Prescription Drug User Fee Act and creating generic drug and biosimilar user fees. Industry and FDA have concluded negotiations for a PDUFA commitment letter, which now is being cleared by the Department of Health and Human Services and Office of Management and Budget. It then will head to Congress for approval, where other initiatives could be attached (Also see "PDUFA V: Emerging Sponsor Communication Issue Resolved And Expanded" - Pink Sheet, 6 Jun, 2011.). Hill said ASHP members want the issue addressed quickly, preferably before PDUFA is considered. He also said there is a risk it could be lost among the “bigger-ticket” items that will be addressed in what is an ever-growing PDUFA bill. “It’s really a non-starter for us to go back to our membership and say ‘Hey, just wait until next year when PDUFA’s up,’” Hill said. “It’s really from our member’s perspective a crisis and we feel that we need to deal with this or begin to deal with this now.” House Version Adds Fines, Other Details Today, only sole-source manufacturers of medically necessary drugs have to report to FDA six months before a product is discontinued. Some shortages were sparked by an increase in drug recalls last year, including among sterile injectables for cancer and other serious conditions (Also see "Another Busy Year of Drug Recalls Led to Shortages of Injectables" - Pink Sheet, 1 May, 2011.). The agency also was asked recently to help deal with supply issues for lethal injection drugs (Also see "Imports Of Lethal Injection Drug A Law Enforcement Issue, FDA Says" - Pink Sheet, 14 Feb, 2011.). Klobuchar’s bill incorporated many recommendations that emerged from a fall 2010 summit intended to determine ways to deal with the problem. Not only did the bill expand reporting requirements to interruptions as well as discontinuations, it also required the agency to identify drug supplies that are vulnerable to shortages and create plans to ensure supply continuity (Also see "Drug Shortages Bill In Senate Would Increase Manufacturing Disclosures To FDA" - Pink Sheet, 14 Feb, 2011.). The Rooney-DeGette bill further clarified the reasons manufacturers could reduce the notification deadline for a discontinuation or supply interruption. Public health or liability problems that could result as well as economic hardship stemming from continued manufacturing were included, as well as the ability to continue distribution for six months. The House bill also quantified the penalty for non-compliance, which had been left to FDA to determine in the Senate version. Rooney and DeGette said the fine for failing to give proper notice would be $10,000 per day a violation continues. The total fine would not exceed $1.8 million for “violations adjudicated in a single proceeding,” according to the bill text. No Power To Force Drug Production FDA established a drug shortage program within CDER in 1998. In 2006, the agency’s Oncologic Drugs Advisory Committee’s Pediatric Oncology Subcommittee called for increased agency authority to deal with shortages following problems with the supply of methotrexate. Committee members at that time were most concerned about preventing shortages, rather than proper notification (Also see "FDA Needs Legal Power To Manage Drug Shortages, Pediatric Subcmte. Says" - Pink Sheet, 20 Mar, 2006.). Continuity plans were envisioned in the two bills to allow the agency to work with the vulnerable manufacturer, its distributors and health care providers to ensure supplies are not interrupted. The House bill does limit that power however, unlike the Senate version. It does not allow HHS the power to force a drug manufacturer to produce a drug in the event of a shortage or supply interruption. The agency also cannot require a discontinuance or interruption to be delayed or altered, according to the bill. That language would seem to indicate market forces would continue to rule and FDA would not have any power to stop a shortage once it occurs, no matter the situation. It also is evidence of industry’s influence over the legislation. Hill said giving the agency those powers likely was not a workable solution and would garner significant opposition. A company also could not be penalized for “allocating distribution of its products in order to manage an actual or potential drug shortage,” according to the bill. Shortages that require companies to essentially ration their drugs can be contentious, especially if the product treats a rare disease. U.S. patients asked FDA earlier this year to create an allocation plan for Genzyme’s Fabrazyme (agalsidase beta) so it could be forced to stop exporting the drug and meet the domestic demand. A viral contamination in a bioreactor at its Allston Landing, Mass. facility forced the plant to temporarily shut down in 2009 and ration its Fabrazyme supply. The petition was an admitted long-shot and came as the company was preparing to re-establish its full manufacturing capacity for the drug. (Also see "Fabrazyme Patients Ask FDA To Retool Genzyme's Product Distribution Plan" - Pink Sheet, 15 Feb, 2011.). |