PHARMACY

Wisc., Mont. face issues on contraceptive decisions by religious pharmacists

BY Drew Buono

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.

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House votes overwhelmingly to block Medicaid cuts

BY Drew Buono

WASHINGTON The full House of Representatives voted yesterday to block cuts aimed at Medicaid, which were proposed by the Bush administration, according to published reports. The spending cuts would have totaled $13 billion over the next five years.

The measure easily passed the mandatory two-thirds vote needed by a vote of 349-62. The vote will hopefully impose a one-year moratorium, through next March, on seven rules changes that the administration argues are needed to clean-up the waste and abuse in the program. The next step is for the vote to move to the Senate Finance Committee in hopes of moving to the Senate floor. President Bush, however, has threatened a veto, so it would be important for the Senate to be overwhelmingly in favor of the vote, as the House was.

The proposed rules would affect programs involving payment to public safety-net institutions, rehabilitation services for people with disabilities, coverage of hospital clinical services, graduate medical education payments and specialized medical transportation to school for children covered by Medicaid.

In 2007, some 48 million people participated in Medicaid programs. The total cost was about $352 billion, with the federal government paying almost $200 billion and states providing the rest.

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Data suggests FDA approving drugs despite delayed studies

BY Drew Buono

WASHINGTON Almost two-thirds of the time, pharmaceutical manufacturers are not even beginning studies that they promised to the Food and Drug Administration upon receiving approval for their drugs, according to Bloomberg. To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to the market. The research is usually voluntary.

The data released yesterday showed that 1,044, or 62 percent, of incomplete studies for both biotech and conventional medications had yet to begin as of Sept. 30. This is an increase compared to the 1,026 studies that had not begun by the same date in 2006.

“Drugs often come on the market with an expectation that studies will be conducted,” said Peter Lurie, deputy director of the Health Research Group at Public Citizen, an advocacy organization. “In fact, many of these studies begin late or do not begin at all.”

Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don’t emerge until products are in widespread use.

Some research has been pending for years. Of the 1,044 studies that hadn’t begun, drugmakers committed before Oct. 1, 2004 to undertake 444 of them, according to the FDA.

The FDA statistics show 271 studies, or 16 percent, were on or ahead of schedule, and 242, or 14 percent, had been submitted for FDA review or terminated before completion. The FDA described 125 studies as “delayed.”

The FDA does not consider all of the uninitiated studies late. Many of them don’t have deadlines, at least not ones imposed by regulators. The agency didn’t specify the number of drugs covered by the studies. Drugmakers sometimes agree to complete multiple studies for a single product.

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