News in brief - Aug. 23/30, 2004

NIH won't override Norvir patent - Stem cell research debated - New York City sues drug makers over Medicaid drug prices - Cost inflation alleged against N.Y. pharmacy benefit manager - Government stalling medical marijuana study, researchers charge

NIH won't override Norvir patent

The National Institutes of Health will not get involved in the fray over Abbott Laboratories' price hike last year for its HIV/AIDS medication Norvir (ritonavir).

In a July 29 letter, NIH Director Elias A. Zerhouni, MD, said the agency would not exercise its power to override Abbott's patent rights to permit production of generics. Members of Congress and consumer groups asked the NIH to act after the company increased the drug's daily price from $1.71 to $8.57. Dr. Zerhouni said the issue would be better addressed by Congress and the Federal Trade Commission.

Stem cell research debated

Presidential candidate John Kerry took aim earlier this month at the Bush administration's stance on federal funding for stem cell research. He questioned the president's commitment to science. Sen. Kerry (D, Mass.) said that if elected, he would lift the ban on federal funding for research using stem cell lines established after Aug. 9, 2001. Since that deadline, more than 100 stem cell lines have been developed, and many of them are considered to be of better quality than the earlier lines.

First lady Laura Bush defended the president's policy. She said the administration is generously supporting research using the existing stem cell lines. In a statement, Dept. of Health and Human Services Secretary Tommy Thompson said, "Before anyone can successfully argue that the existing federal stem cell policy needs to be broadened, we must first exhaust the potential of the stem cell lines made available within the policy."

New York City sues drug makers over Medicaid drug prices

The City of New York filed suit Aug. 5 against 44 pharmaceutical companies it accuses of Medicaid overcharges that cost the city millions. The complaint alleges that the companies inflated the prices used to determine Medicaid drug reimbursements and that by reporting false price information they underpaid Medicaid the rebates the federal government requires. The city is seeking to recover its 25% share of the program overcharges and triple damages.

Cost inflation alleged against N.Y. pharmacy benefit manager

New York Attorney General Eliot Spitzer in August sued Express Scripts Inc., accusing the nation's third largest pharmacy benefit manager of inflating prescription drug costs for the state's employee health program, the Empire Plan.

The lawsuit alleges that the company inflated generic drug costs, diverted to itself millions of dollars in manufacturer rebates that belonged to the Empire Plan and fraudulently got physicians to switch patients' prescriptions to drugs for which Express Scripts received rebates.

In a statement, Express Scripts said it "strongly denies" the allegations and would "defend itself vigorously." The company said it had saved the state of New York more than $2 billion in drug costs since 1998. Express Scripts said New York had received all the rebates for which it contracted.

Government stalling medical marijuana study, researchers charge

In late July, researchers filed a lawsuit against several government agencies they charge with obstructing medical marijuana research.

Lyle Craker, PhD, the director of the Medicinal Plant Program at the University of Massachusetts, Amherst, is asking the court for help in getting a decision on an application that he filed with the Drug Enforcement Administration in June 2001. He asked for the agency's approval to establish a facility that would produce marijuana for Food and Drug Administration-approved research. Despite an October 2003 letter of support from two senators, Dr. Craker still has not received a response.

The DEA, Dept. of Health and Human Services, National Institutes of Health, and National Institute on Drug Abuse are targets of the lawsuit filed in federal court in Washington, D.C.