News in brief - Oct. 2, 2006

HSA users satisfied, GAO finds - Compounded drugs don't need FDA approval, federal court rules

HSA users satisfied, GAO finds

People with health plans eligible for use with health savings accounts are generally wealthier than their peers and happy with their coverage, according to a recent U.S. Government Accountability Office report. But they aren't shopping around for deals on hospital or physician care.

"Contrary to the hopes of [consumer-directed health plan] proponents, few of the HSA-eligible plan enrollees who participated in our focus groups researched cost before obtaining health care services," the report concluded. The exception was prescription drug costs. Some participants said they were uncomfortable asking doctors about their prices.

HSA-eligible plans typically had lower premiums and higher deductibles than traditional plans, but both covered similar services and used similar physician and hospital networks, the GAO found.

Although plan participants generally reported positive experiences, most said they would not recommend them to everyone. They would suggest HSAs to healthy consumers but not to people who rely on medications, have a chronic condition, have children or lack the financial resources to meet the high deductible. The report, GAO-06-798, is available online (www.gao.gov).

Compounded drugs don't need FDA approval, federal court rules

A Texas federal court on Aug. 30 ruled that pharmacists who compound drugs to prepare medications based on a physician's order are not creating new drugs unapproved by the Food and Drug Administration.

"If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval," states the ruling by the U.S. District Court for the Western District of Texas, Midland-Odessa Division.

The court said that unless the FDA can demonstrate that the pharmacies are not compliant with state laws for dispensing medications, regulators can only conduct "limited inspections." Drugs that are compounded in bulk before a prescription is received, however, are not exempt from FDA scrutiny, Judge Robert Junell noted. At press time, the FDA had not returned calls for comment.