FDA News Roundup
The FDA warned Monday that "escalating" rates of antibiotic-resistant human diseases "demand a sweeping reexamination" of the use of the drugs on U.S. farms, the Atlanta Journal-Constitution reports. Calling the link between use of antibiotics on farms and some human diseases "indisputable," the FDA proposed regulations that may for the first time prevent farmers from using antibiotics that "promote the spread of resistant human pathogens." While the agency has confirmed the spread of resistant microbes from farms to human populations in "only a few" of the 106 antibiotics used in animals, FDA officials called the risks "serious enough" to warrant action. "FDA's primary goal must be to protect the public health by preserving the long term effectiveness of antimicrobial drugs for treating diseases of humans," Stephen Sundlof, director of the agency's Center for Veterinary Medicine, said during a three-day public hearing on the proposal in Rockville, Md. Under the proposed rules, the FDA would establish a "regulatory framework" and set "specific thresholds" where the "appearance of resistance" would trigger an "automatic halt" to agricultural uses of a drug. The regulations -- which could require congressional approval -- would apply to new drugs developed for agricultural use after the rules took effect, but could also apply to antibiotics "already in use" (Toner, Atlanta Journal-Constitution, 1/23). The proposed FDA rules come after the Union of Concerned Scientists, a Massachusetts-based not-for-profit group, released a 109-page report earlier this month warning that the drug and livestock industries have largely underreported the use of antibiotics in pigs, cows and chickens -- a routine practice to promote growth and prevent infections.
In a separate action, the FDA may prevent the poultry industry from using quinolone antibiotics that the agency blames for a "sharp increase" in resistance among campylobacter microbes, which cause an estimated 2.4 million cases of "food poisoning" each year. According to the Journal-Constitution, however, the process may prove "long" and "contentious," with the poultry industry and Bayer Corp., the pharmaceutical company that manufactures the drug, challenging the ban. Public health advocates argue that the FDA should take "swift action." Richard Wood, executive director of the Food Animal Health Concerns Trust, a Chicago-based food policy group, said, "The first concern has to be human health. When you're trying to save an important antibiotic, due process that takes years to accomplish is unacceptable." The new rules could prove "especially restrictive" for several classes of antibiotics, considered "drugs of last resort" -- including quinolones, vancomycin and certain cephalosporins -- for some human infections (Atlanta Journal-Constitution, 1/23).
In other FDA news, the agency is warning that a counterfeit version of Serostim, a prescription injected medicine that helps fight wasting syndrome in AIDS patients, has appeared in seven states and could cause "dangerous" side effects in "unsuspecting users." The AP/Baltimore Sun reports that the FDA has begun a criminal investigation to track down the counterfeit drug's manufacturer and distributor. Serono Inc, which manufactures Serostim, "alerted" pharmacies and AIDS organizations to the counterfeit drugs last month. The composition of the fake drug is unknown, and reported side effects include skin irritation and redness on the area of the skin where the drug is injected. In addition, AIDS patients risk getting worse if they go without their real Serostim prescription. Counterfeit batches, which patients have received through pharmacies, have been reported in California, Kentucky, Michigan, New Jersey, Florida and Missouri. Patients should look for the fake drug's lot number MNK612A, which is also a real lot number for authentic Serostim. Patients can distinguish the fake version by its expiration date, 08/02. The real Serostim has an expiration date of 08/01. About 6,000 AIDS patients use Serostim (AP/Baltimore Sun, 1/23).
The FDA approved yesterday the once-a-week hepatitis C drug Peg-Intron, which is a new version of the "longtime" hepatitis treatment interferon-alpha that is made with new "pegylation" technology, the AP/Ft. Lauderdale Sun-Sentinel reports. Manufacturer Schering-Plough Corp. said that the weekly injections are "twice as effective" as regular interferon, taken three times a week. Schering also manufactures the "top" hepatitis C treatment Rebetron, a combination therapy of interferon and Ribavirin. Some studies suggest Rebetron may be more effective than Peg-Intron, but FDA hepatitis chief Dr. Bill Schwieterman said that Peg-Intron may cause fewer side effects because Ribavirin "raises risks of hemolytic anemia, heart dysfunction and other effects." However, patients taking Peg-Intron are one and a half times more likely to have "mild bone marrow suppression," Schwieterman added, something that the FDA "suggested doctors monitor." Peg-Intron will be available next month for a wholesale cost of $962 to $1,114 a month, cheaper than Rebetron, which has a wholesale cost of $1,560 a month (AP/Ft. Lauderdale Sun-Sentinel, 1/22).
Bernard Schwetz, a deputy to former FDA Commissioner Jane Henney, will serve as acting head of the agency until President Bush appoints a "permanent successor." Last Thursday, Henney learned that she "would not be retained" in the new administration. Schwetz headed the FDA's National Center for Toxicological Research from 1993 to 1999 (Philadelphia Inquirer, 1/23).