California Officials Push for Changes to FDA Recall System for Drugs

After California regulators fined 94 hospitals for not removing heparin from their pharmacies after the drug was recalled, state public health officials are arguing that FDA's recall system is not working properly, the Los Angeles Daily Journal reports (George, Los Angeles Daily Journal, 10/22).

Earlier this month, the Daily Journal's review of state citations showed that some California hospitals continued to administer heparin to hundreds of patients, despite a recall of the blood thinner months before (California Healthline, 10/2).

In total, 94 California hospitals have been fined by state regulators for failing to remove the drug after warnings went out.

In the case of UC-San Francisco Medical Center, officials said that they removed heparin from the hospital pharmacy when they received the recall notice.  However, officials maintain that they received additional doses of recalled heparin from a drug supplier that had not received FDA's recall notice.

Daily Journal interviews with several pharmacy directors who did not remove heparin from their hospitals suggest possible communication lapses in the recall system. In the interviews, some pharmacists said they never received recall notices, and others said they received numerous notices, raising questions about which heparin-related products were being recalled.

Loriann DeMartini, chief of the pharmaceutical program for California's Department of Public Health, said, "Whatever happened in California is happening in other states as well," adding, "We have a system that is in need of repair."

Pharmacist groups, hospitals and state officials have raised the possibility of reworking the recall system at the state level, possibly through new legislation.

FDA Response

Joseph Famulare -- deputy director of the office of compliance at FDA's Center for Drug Evaluation and Research -- argued that the recall system is working effectively.