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NY Gov Wants New Regs on Gifts to Docs

From Associated Press (January 25, 2010)

ALBANY, N.Y.--(AP)--New York Gov. David Paterson is proposing new, tougher prohibitions on pharmaceutical companies, restricting them from dispensing gifts and misleading production information to doctors while promoting the use of specific drugs.

The pharmaceutical industry is fighting the proposal, arguing in part that the federal government already regulates its marketing practices.

New York would join at least nine states that have enacted legislation affecting pharmaceutical marketing, according to the National Conference of State Legislatures.

"This will benefit patient care and reduce costs in the Medicaid program, as more expensive drugs will not be prescribed for the wrong reasons," Paterson said.

Paterson wants to prevent pharmaceutical companies from influencing the prescribing habits of doctors.

"Cracking down on the gifts that the drug industry gives to doctors could lead to more independent prescribing by physicians," said Bill Ferris, a lobbyist for AARP, an advocacy group for older Americans. "Doctors are constantly being solicited to prescribe high-cost brand name drugs when equally effective less expensive drugs may be available."

The Paterson administration estimates the change will generate little money for the state through cutting the spending on prescription drugs, but argues it's important for New Yorkers to know they are being prescribed medications for the right reasons.

Pharmaceutical companies argue Paterson's measures go beyond the current voluntary code by interfering with the relationships between doctors and experts who act as consultants for the companies.

"This proposal calls for unneeded government intrusion into a competitive private marketplace that is already working well," said Jan Faiks, vice president of Pharmaceutical Research and Manufacturing of America, which lobbies on behalf of the industry.

Faiks said Paterson's proposal is unnecessary because the industry already has a voluntary code of conduct. The pharmaceutical industry also points out that the Food and Drug Administration's Division of Drug Marketing, Advertising and Communications already regulates their marketing practices.

"That code is voluntary, not all of the companies have adopted the code and there are no enforcement standards," said Lisa Ullman, assistant counsel to the governor. She said Paterson's plan makes mandatory most of the things already included in the voluntary guidelines and creates new oversight.

Under Paterson's proposal, pharmaceutical companies that violate the law would be fined between $15,000 and $250,000 per violation, and health care professionals would be fined between $5,000 and $10,000 per violation. The state Department of Health would be responsible for enforcement, but would rely on complaints to identify violators.

The FDA reviews promotional materials to ensure that they are truthful, scientifically accurate and consistent with the product's FDA-approved labeling. They also travel to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities.

Posted: January 2010