Disclosures on docs
States are passing laws that require manufacturers to disclose payments and gifts to healthcare professionals. Such requirements
have been enacted in Minnesota, Vermont, West Virginia, Maine, and, most recently, Massachusetts. A long list of states, including
California, Texas, Illinois, and New York is considering such laws. These statutes generally seek data about fees, gifts,
and educational grants to healthcare providers and organizations, but policies vary considerably as to which expenditures
have to be disclosed and when.
In addition, federal and state enforcement officials are including disclosure requirements in corporate integrity agreements
(CIAs) negotiated with drug companies to resolve allegations of fraudulent promotional and pricing practices. Prosecutors
have put an "emphasis on transparency" in industry relationships with physicians and in results from clinical trials, said
US attorney Michael Loucks at CBI's Pharmaceutical Compliance Congress in January 2009.
Under a comprehensive CIA, negotiated as part of Eli Lilly's record $1.4-billion settlement involving "Zyprexa" sales and
marketing, Lilly will post quarterly reports on its website about payments to physicians, including speaker and consulting
fees, grants, gifts, food, and travel. Last year, Cephalon (Frazer, PA) similarly agreed to report all payments to physicians
as part of its $375-million settlement with federal and state prosecutors to resolve allegations of improper marketing practices
for three medications. Bristol-Myers Squibb's 2007 CIA includes requirements for reporting listed prices to state Medicaid
programs to ensure accurate pricing.
Disclosure demands from prosecutors and state legislators are building industry support for federal transparency legislation
that would preempt state laws. In January 2009, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) introduced an updated
version of the Physician Payments Sunshine Act. The bill expands public disclosure of financial relationships between physicians
and manufacturers of drugs and medical products that are covered by Medicare, Medicaid, or other government health programs.
The revised bill calls for manufacturers to file reports on payments to physicians that exceed $100 a year (down from a previous
$500 threshold) plus any substantial investment interests held by doctors. Companies also would compile annual reports of
total payments and breakouts for each state.
Such expanded disclosure is supported by the Medicare Payment Advisory Committee (MedPAC) in its March 2009 report to Congress.
The advisory group wants to collect more payment data to better assess whether industry–provider financial relations affect
Medicare prescribing, drug use, and expenditures. MedPAC also wants information about drug samples distributed to doctors
and other parties to determine whether providing $20 billion in free medicines each year has an identifiable impact on prescribing
decisions. FDA currently requires companies to keep records on samples handed out by sales representatives to guard against
illegal diversion, but does not ask for regular reporting of sampling activity.
Under the Sunshine Act, all this payment information would be stored in a national database of physician–industry relationships.
Public and private payers and health plans thus would be able to uncover and assess relationships between industry payments
and physicians' practice patterns. The trade-off for manufacturers is supposed to be federal preemption of state disclosure
laws that require different information about payments to physicians. It's not clear how comprehensive that preemption will
be in the final legislation, however. Though some MedPAC members recognize that industry–doctor relationships can help advance
the development of new technology, the broad consensus is that making health professionals' links to pharmaceutical marketing
known to all will discourage inappropriate relationships.