September 24, 2007

Volume 1, Number 31
Brought to you by Thomas Jefferson University’s Department of Health Policy

Media Industry Helped Drug Firms Fight Ad Restraints

Direct-to-consumer advertising was largely spared from new restrictions in the legislation, in
part because the drug industry has found powerful allies among media and advertising firms who
were determined to protect one of their biggest and fastest-growing advertising categories. The
toughest drug-ad restriction in early drafts of the bill gave the FDA authority to block a drug
company from advertising a medication that carried serious safety concerns. That was left on the
cutting-room floor. The FDA will get new power to require drug companies to submit TV ads for
review before they run, but it can only recommend changes, not require them. The bill lets the
agency levy fines for false and misleading ads (Wall Street Journal, 9/21).

N.J. weighs requiring reporting doctors' gifts

A New Jersey task force will convene for the first time on Wednesday to consider whether the
state should require pharmaceutical companies and medical device makers to disclose gifts they
give to physicians. The task force will examine the effects of drug and device makers' gifts and
fees to physicians on the doctor-patient relationship, as well as how much gift-giving informs
physicians about new treatments. The task force also will examine ways to prevent and identify
abuses, including requiring public disclosure of gifts, limiting payments physicians can accept or
requiring doctors to inform patients about such payments. Bills that call for reporting payments
to doctors by pharmaceutical and medical-device firms have passed in four states - Vermont,
Maine, Minnesota and West Virginia - and the District of Columbia.
(Philadelphia Inquirer, 9/19; AmericaHealthLine, 9/19). More at:
http://www.philly.com/philly/business/homepage/20070919_N_J__weighs_requiring_reporting_doctors_gifts.html

Bill Raising FDA's Powers Nears Passage

Congress moved closer to passing a final version of a bill that would give the Food and Drug
Administration new power to restrict medications that raise safety concerns, in what would be
the biggest expansion of the agency's authority in a decade. The bill, which was overwhelmingly
passed by the House yesterday, would bolster the FDA's authority over drugs once they are
released on the market. Under the bill, the FDA would be able to take various actions if it
believes a drug carries a potential safety concern, including the ability to require new studies,
limit distribution or order label changes. The FDA would also be required to monitor drugs after
they go on the market, and the agency would get new funding for that job. The bill would also
force companies to make public some of the results from their studies (Wall Street Journal, 9/20)

Any questions regarding this newsletter can be directed

to Vittorio Maio at vittorio.maio@jefferson.edu.