FDA requests more information before approving mipomersen
CAMBRIDGE, Mass., and SAN FRANCISCO Isis Pharmaceuticals and Genzyme recently announced that the Food and Drug Administration has asked for more study data about its cholesterol drug mipomersen, according to the Associated Press.
As a result, the companies have stated that the drug will face at least a one-year delay as they gather the necessary information. The drug candidate is in late-stage development, but the FDA said it will require data from two ongoing preclinical studies testing whether or not mipomersen causes cancer. The companies anticipate filing an application with the FDA in 2010.
Mipomersen is in the last stage of clinical trials as a treatment for a rare genetic disease that causes people to have extremely high cholesterol levels, raising their risk of premature cardiovascular disease and death. There are only about 10,000 people in the world with the most severe form of the disease, which can cause heart attacks even in young children.
The two companies signed a deal back in early January, under which Genzyme paid $150 million to purchase a stake in Isis, who was developing the drug.
Wisc., Mont. face issues on contraceptive decisions by religious pharmacists
MADISON, Wisc., and HELENA, Mont. The Thomas More Society, a law firm that represents abortion opponents recently asked the Wisconsin Supreme Court to hear an appeal of a disciplinary action brought against a pharmacist who refused to fill a prescription for birth control because of his religious beliefs, according to published reports.
The pharmacist, Neil Noesen, refused to fill a birth control prescription for a University of Wisconsin-Stout student in July 2002. He also declined to transfer the prescription to another pharmacy.
The woman filed a complaint with the state Department of Regulation and Licensing’s Pharmacy Examining Board. The board adopted the findings of an administrative law judge that Noesen be reprimanded and that limitations be placed on his license. He also was ordered to take an ethics course and required to pay $21,000 in costs.
The decision was upheld by a circuit judge and by the 3rd District Court of Appeals, although the appellate decision ordered a review of the order that Noesen pay costs.
In related news, the Montana Board of Pharmacy took no action this week after hearing comments on the issue of pharmacists who refuse to dispense contraceptives because of religious beliefs. Montana currently has no rule or statute that requires pharmacies to stock every drug on the market, and “we decided to leave it at that,” board president Jim Cloud said.
Board member Mark Meredith said that a decision on whether new regulations are necessary should come from state lawmakers, not the six-member pharmacy board.
Stacey Anderson, director of public affairs for Planned Parenthood of Montana, who requested the meeting with the board, urged it to establish a rule that protects women’s access to birth control. She asked board members to be proactive in addressing the issue to “prevent future personal refusals and to clearly define the standard of care expected of licensed pharmacies.”
After the meeting, Anderson said her organization will continue to look for ways to make its case through “administrative and legal avenues.” She added that she doesn’t agree that the issue should be decided by the state’s lawmakers.
FDA commissioner stresses importance of information technology
WASHINGTON According to Food and Drug Administration commissioner Andrew von Eschenbach, information technology is one of the top priorities in the agency, according to published reports.
Von Eschenbach spoke earlier this week before the House Energy and Commerce subcommittee on oversight and investigations, which is studying FDA actions to improve the safety of medical devices and products made with foreign components.
The FDA, von Eschenbach said, needs a modern information technology infrastructure to better use data it already has and to better coordinate various activities within the agency. Existing information systems, for instance, do not have the capability to automatically verify information submitted by foreign firms that ship components of regulated products into the United States.
“FDA plans to enhance its I.T. systems in ways that will enable the agency to better utilize risk-based information from the entire life-cycle of imported products,” von Eschenbach testified. “Many of these improvements will be implemented in the next two years; implementation of a few will extend beyond 2010. These projects will improve databases, enhance interoperability of systems within the agency and among other regulatory agencies, and provide better analytical function to assess and control risk.”