Dec 6, 2012
Government watchdog group sues FDA for data on ag antibiotic use
The Government Accountability Project (GAP), a government watchdog group, yesterday announced the filing of a lawsuit aiming to force the US Food and Drug Administration (FDA) to release more data on the sale of antibiotics for use in food animals. GAP noted that the Animal Drug User Fee Act requires drug companies to report to the FDA certain information about antibiotic sales, including the amount of each drug sold, the animals intended for treatment, and whether drugs are formulated for use in water, feed, or injections. The FDA releases a limited summary of the data each year but withholds most of it, according to GAP. The group said it is suing the FDA because the agency denied a Freedom of Information Act request filed in February 2011 for information on the amount of animal antibiotics sold in 2009. The FDA said the requested information was "confidential commercial information," according to GAP. The group shares the view of many experts that the misuse of antibiotics in food animals contributes to the development of antibiotic resistance that makes human illnesses harder to treat. In April the FDA announced a strategy designed to induce drug companies, veterinarians, and farmers to voluntarily reduce the use of antibiotics in food animals.
Dec 5 GAP press release
FDA measures could ease approval of new antibiotics
An FDA committee's Nov 29 endorsement of the experimental antibiotic telavancin (Vibativ), a derivative of vancomycin, hinted at promising changes in clinical trial requirements for antibiotics that have hampered the approval of new ones, according to a Dec 4 Nature News story. Vibativ is made by Rib-X, a drug company based in New Haven, Conn. The FDA tightened its clinical trial requirements after reports of liver failure in the antibiotic telithromycin (Ketek) surfaced in 2007, which stopped the flow of newly approved antibiotics at a time when concerns were rising about antibiotic-resistant infections, especially in patients hospitalized with pneumonia, according to the report. The FDA's tougher clinical trial rules required companies to show that patients weren't more likely to die within 28 days of taking the drug, which is difficult to capture in trials containing hospitalized patients with multiple medical conditions. However, over the summer Congress passes new measures to encourage antibiotic developments, along with a vow to "reboot" the antibiotic approval process, Nature reported. In September the FDA said it would reassess telavancin, which brought about the recent vote. David Shlaes, an antibiotic consultant from Stoughton, Conn., told Nature News that he was cautiously optimistic about the changes, but noted the FDA still seems to be focusing on all-cause mortality.
Dec 4 Nature News story
House members unveil compounding pharmacy legislation
Two US House representatives yesterday introduced legislation to improve the oversight of compounding pharmacies and to clarify the FDA's role, according to a statement from the office of Rep Rosa De Lauro, D-Conn. The proposed law, called the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, was also introduced by Rep Nita Lowey, D-NY. In her statement, De Lauro said news this week of more contamination findings in additional products from New England Compounding Center (NECC) shows that the incident wasn't isolated. "We must end the current regulatory morass so that no more lives are placed at risk," she said. So far 541 infections and 36 deaths have been linked an injectable steroids from NECC, and the Centers for Disease Control and Prevention (CDC) this week asked health providers to be alert for other infections, including bacterial ones, related to three of the company's other products. The outbreak prompted two recent Congressional committee hearings. Federal and state officials described regulatory gaps, but some legislators said the agencies already have rules in place to enforce safety issues at the pharmacies. The legislation is unlikely to move forward in the House this year due to the short time remaining and a focus on deficit-reduction talks.
Dec 5 Rep De Lauro statement
Dec 5 Reuters story
2011-12 campus mumps outbreak highlights unique challenges
A California university mumps outbreak in the fall and winter of 2011-12 highlighted the importance of early reporting—which may face unique obstacles on campuses—and the reality that even two vaccine doses may not always protect students, according to a report today in Morbidity and Mortality Weekly Report (MMWR). The 29-case outbreak at the University of California-Berkeley, which lasted until Jan 7, 2012, began when an unvaccinated student who had traveled to Western Europe during its mumps outbreak reported mumps-like symptoms on Aug 25, 2011. Of the 29 patients, 8 (28%), including the index patient, participated in sports; 17 (59%), including the index patient and his roommate, lived in congregate housing; and, 22 (76%) had not received the recommended two doses of the measles, mumps, and rubella vaccine. The report specifies the index patient's roommate as one of those who were fully vaccinated but still contracted the disease (it cites a median vaccine effectiveness of 88%). The authors also estimate that at least two generations of transmission had occurred before public health authorities were notified. They attribute the reporting delay at least in part to patient-confidentiality laws, as public health officials had to declare an emergency before they could gain access to students' medical records, which are considered educational records under the federal Family Educational Rights and Privacy Act.
Dec 7 MMWR report