A surge of new laws and regulations
are in the works that will require pharmaceutical and
medical-device companies to disclose all gifts to health-care
providers or eliminate commercially supported continuing medical
education.
The Massachusetts state senate passed
legislation this spring that bans pharmaceutical and medical-device
companies from giving payments and gifts, including travel and
honoraria, to health-care providers. California, Minnesota and
Vermont have passed similar laws, and during 2007 alone at least 27
states proposed legislation requiring marketing disclosures by drug
manufacturers, according to the National Conference of State
Legislatures.
“It’s such a dynamic area, it’s always
changing,” said Kristine Rapp, vice president of global ethics and
compliance for Hospira Inc., a pharmaceutical and medication
delivery firm based near Chicago. “As states enact different laws,
the task facing companies’ compliance functions becomes more
complex.”
Further complicating matters is the
possibility of a nationwide disclosure law. The Physician Payments
Sunshine Act of 2008 was introduced in March in the House of
Representatives and if passed would require every manufacturer of a
drug, device or medical supply to submit a report on gifts
exceeding $25. Manufacturers who don’t comply can be fined up to
$100,000 per infraction.
Rapp said industry professionals are
concerned with laws that require pharma and medical-device
companies to disclose their gifts because of the extra work this
creates, not to mention the challenge of developing an accurate
tracking system. “These requirements will be burdens on any
company,” she said, “and the reporting adds costs.”
Also of concern is a proposal from the
American Medical Association’s Coun-cil on Ethical and Judicial
Affairs that would ultimately ban health-care providers from
receiving any funding for medical education. Although it was tabled
by the council in June, it could be on the agenda again next
year.
In a seemingly preemptive move, New
York City-based pharmaceutical giant Pfizer announced last month
that it would stop awarding grants to medical education and
communication companies, although it will continue to support CME
programs at medical centers, teaching hospitals and via certain
other suppliers if they meet the stringent requirements thata have
been established by the Accreditation Council for Continuing
Medical Education.