Advocates Push for Advanced Warning of Drug Shortages
Production problems and difficulty in obtaining raw materials are creating a shortage of more than a dozen medications, including antibiotics and surgical anesthetics, USA Today reports. While industry officials say there is "no cause for alarm," experts say that the shortages will "likely get worse." The reasons for the shortages vary, but include "smaller inventories" at hospitals, increased FDA quality enforcement and industry consolidation that has resulted in fewer manufacturers. USA Today reports the shortages are having an impact on patients. For example, hemophiliacs are being cautioned to delay elective surgery until "production problems" are corrected at a Bayer plant in California. Joseph Deffenbaugh, who tracks shortages for the American Society of Health-System Pharmacists, said, "It's a shrinking world. There are fewer manufacturers making the bulk materials and fewer making products." Many manufacturers exit the market for certain drugs because of "low sales." Others, such as American Home Products, stopped making certain drugs because required upgrades for production facilities would have cost more than the products were worth. Despite the shortages for some drugs, the industry says that news organizations are "blowing shortages out of proportion." Jeff Trewhitt, with the Pharmaceutical Research and Manufacturers of America, said, "We haven't seen definitive data that shows there is a problem. For the patients involved, it certainly is a big problem, but from a big picture perspective, they have cited a handful of examples of shortages or stopped productions out of 25,000 pharmaceutical products on the market."
This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
USA Today reports that to alleviate the shortages, some doctors and pharmacists say the government needs to "provide better scrutiny" when a manufacturer exits the market. Federal law requires producers to give six months notice before production of a "medically necessary" drug is halted, but the FDA typically does not determine if a treatment is necessary until it is "already in short supply." Also, if "sudden" production problems arise or there is a shortage of materials, "notice can't be given." Even if firms do not provide notice, the FDA can not impose fines or force production. "We have to give approval for companies to make the drugs, but companies can leave the marketplace anytime they wish," said Mark Goldberger, who coordinates the agency's drug shortage response. To help public health officials "plan" for shortages, Mohammad Akhter, executive director of the American Public Health Association, said that firms should be required to "give a year's notice" before production is halted, which would give other producers time to "step in" to meet the demand. However, this would require a new law from Congress. Instead, Goldberger said the agency needs to find "new ways" to handle firms leaving the market. "We would like to talk more with industry and see if there are things we can do without legislation to improve communications." While there have been "no hearings" scheduled on the problem, USA Today reports that the shortages "concern" some members of Congress. Rep. Henry Waxman (D-Calif.) said, "Public health authorities, physicians and American families must receive early notice if a company stops production on a vaccine. Vaccine manufacturers receive a number of special incentives and legal production from the government. Such advance notice is the least we can expect in return." Alan Goldhammer, vice president of regulatory affairs for PhRMA, said that "more regulation" in not needed, but that hospitals need to examine their inventory procedures. "Just-in-time inventory" -- in which hospitals keep smaller drug supplies on hand to reduce use -- "is based on average use. If you have above average use, then you have an issue" (Appleby, USA Today, 7/11).