31 Organizations Call for Safe Drug Manufacturing Reforms in PDUFA
Late yesterday, thirty advocacy organizations, representing seniors, labor, providers, patient safety advocates, cancer patients, and consumers joined Community Catalyst in calling for Congressional action to improve the safety of drug manufacturing. In letters to the Senate HELP and House Energy and Commerce committees, groups urged Congress to make safe drug manufacturing legislation a priority by including new patient safeguards “in the upcoming reauthorization of the Prescription Drug User Fee Authorization Act (PDUFA).”
Signed by advocacy groups from across the nation and in districts of some key Energy and Commerce committee members, the letters warns that the many recent drug recalls, failed inspections, and manufacturing quality breakdowns by both brand-name and generic manufacturers are likely just “the tip of the iceberg” because most manufacturing problems at overseas facilities go unseen.
The high profile manufacturing problems by Johnson and Johnson, GlaxoSmithKline, and other facilities were discovered primarily by FDA visits to the 2,500 domestic drug manufacturing plants, which are inspected once every two and a half years. But the number of foreign drug manufacturers has doubled in the last seven years, encompassing approximately 3,800 foreign manufacturers in more than 150 countries.
This rapid globalization of overseas drug manufacturing has far outstripped the FDA’s capacity to inspect these new facilities, which today are the source of 40 percent of finished drug products taken in the U.S., and 80 percent of active drug ingredients and bulk chemicals used to make drugs domestically. According to the GAO, under current resources, the FDA can inspect these 3,800 foreign sites only once every nine years.
The letters show that these risks are real, serious, and potentially lethal for vulnerable patients. For instance, the intentional contamination of heparin tragically led to numerous deaths and hundreds of adverse reactions amongst the hundreds of thousands of dialysis or post-operative patients treated with Heparin each year.
We also noted how these risks are not floating under the radar, but are widely known by industry leaders. A 2010 poll of pharmaceutical executives identified “raw materials imported from outside the U.S. as the greatest vulnerability” to the purity and integrity of drug products in the next five years. But progress has been made. Our letter commends how the generic drug industry has “stepped up to the plate” by “agreeing to fund inspections with user fees….” See here and here.
Reform is also widely supported by voters from across the political spectrum. In fact “81 percent of Republicans, 87 percent of Independents, and 97 percent of Democrats support increased FDA authority to issue recalls, destroy contaminated products upon import, and inspect foreign manufacturers” according to a recent poll.
The letter asks Congress to provide FDA with new authority to adequately protect US patients from the increasing risks of counterfeit drugs, a leading black-market enterprise around the world. This would include the ability to issue a recall, or to destroy contaminated, expired, or unsafely manufactured drug products that are seized at the border.
Yesterday, Rep. Michael Burgess, vice chairman of the House Energy and Commerce Subcommittee on Health, announced that reforms to end drug shortages would be included in legislation to renew the system of collecting fees from drug-makers in order to fund FDA review of new drug products. We support efforts to eliminate drug shortages, and improvements to drug manufacturing quality would certainly help. According to the FDA, manufacturing problems were the cause of over half of the drug shortages in 2010. And these problems can be quite serious, with sterile drugs found to be contaminated with “glass shards, metal filings, and fungal or other contamination” according to an FDA report last month.
Thanks to our partners who joined us in calling for increased safety of drug manufacturing:
Action for Boston Community Development (ABCD) AFSCME Alliance for Retired Americans Breast Cancer Action California Alliance for Retired Americans (CARA) Center for Medical Consumers Community Catalyst Connecticut Center for Patient Safety Consumers Union Families USA Florida CHAIN Health Law Advocates of Louisiana, Inc. Illinois Public Interest Research Group (Illinois PIRG) Medicare Rights Center Mississippi Human Services Coalition Missouri Alliance for Retired Americans National Education Association (NEA) National Labor Alliance of Health Care Coalitions National Physicians Alliance National Research Center for Women & Families / Cancer Prevention and Treatment Fund. National Women’s Health Network New Hampshire Alliance for Retired Americans North Carolina Justice Center’s Health Access Coalition Ohio Alliance for Retired Americans Pennsylvania Public Interest Research Group (PennPIRG) TeamstersCare – Teamsters Union 25 Health Services & Insurance Plan Texas Alliance for Retired Americans UHCAN Ohio USAction USPirg Vermont Public Interest Research Group (VPIRG)