Setting a National Standard
This proliferation of reporting requirements has generated industry support for federal transparency legislation that would
pre-empt state laws. In January, Grassley and Sen. Herb Kohl (D-WI) introduced an updated version of the Physician Payments
Sunshine Act to expand public disclosure of financial relationships between physicians and medical product manufacturers.
The revised bill calls for manufacturers to report payments to doctors that exceed $100 a year (down from $500), as well
as substantial investment interests held by doctors.
In its March report to Congress, the Medicare Payment Advisory Committee (MedPAC) supported such reporting to better allow
them to assess whether industry–provider financial relations have an impact on Medicare prescribing, drug utilization, and
expenditures. MedPAC also wants data on drug samples distributed to doctors to determine whether billions of dollars in free
medicines have an identifiable impact on prescribing decisions. FDA currently requires companies to keep records on samples
handed out by sales reps to guard against illegal diversion, but does not routinely collect that information.
Under the Sunshine Act, all of this payment information would go into a national database of physician–industry relations.
Public and private payers thus would be able to assess ties between industry payments and physician practice patterns. The
trade-off for manufacturers is supposed to be federal preemption of state disclosure laws that require different information
on payments to physicians. However, it's not clear how comprehensive that preemption will be in any final legislation.
Meanwhile, manufacturers are establishing their own transparency policies and programs. Eli Lilly, Merck, GlaxoSmithKline,
and Pfizer have announced plans to post data on financial relationships with health professionals, and some companies are
setting total annual caps on payments to individual physicians to reduce opportunities for undue influence.
Academic research centers and medical societies are also beefing up financial disclosure policies. The Cleveland Clinic plans
to publicly report relationships of staff doctors and scientists with pharmaceutical and medical device makers. Stanford University,
the University of Pennsylvania, and branches of the University of California in Los Angeles and San Francisco have adopted
stricter conflict-of-interest policies. The North American Spine Society announced in January that the 5,000 spine surgeons
in the organization will disclose all financial ties with medical product companies; psychiatrists are contemplating a similar
While pharma relations with researchers are critical for developing new technology, reformers hope to discourage inappropriate
relationships by putting health professionals on notice that any links to pharmaceutical marketing will be known to all.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at email@example.com