Research Covered
Scrutinizing Samples
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While a number of states exempt fees paid to HCPs for conducting clinical trials, the federal law explicitly brings clinical
research under the aggregate spend umbrella. Sunshine advocates believe that pharma companies may influence prescriber behavior
by engaging physicians as clinical investigators, consultants, and advisors—in addition to their commercial encounters.
But obtaining research-related data will be challenging. Pharma R&D and medical affairs staffs don't see themselves as part
of marketing and are not accustomed to pulling investigator fees out of large research budgets. There's confusion over disclosure
specifics, such as its application to interventional versus observational studies or to equipment supplied to a clinical site
on a temporary basis. This is "unchartered territory," commented Wanda Toro, president of Bull's Eye Innovations, at the CBI
forum.
Another complication is that the federal legislation allows companies to delay public disclosure of fees related to clinical
research until after product approval by FDA, or four years after the payments made, whichever comes first. Sponsors sought
this provision as a way to retain some secrecy about investigational programs. But because companies still have to submit
payment data every year, they must identify what falls into the clinical spend "bucket" to benefit from delayed disclosure.
Just what HHS and others do with all the aggregate spend information remains to be seen. Beginning in September 2013, the
government will start posting payment reports on a public database in a format that is searchable and easily aggregated and
downloaded. HHS also will provide Congress with an annual report aggregated by reporting company, and each state will receive
a summary of payments to its licensed practitioners.
Public disclosure of physician payment data is expected to have a substantial effect on pharma-HCP relationships. Many doctors
have become reluctant to make speeches on specific drugs or to consult on research projects. Investigators maintain that they
have nothing to do with marketing and are unhappy about public disclosure of their research fees and the implication that
such work compromises a physician's independence.
Pharma companies may benefit in the long term from better information and tracking systems. But for now, they're overwhelmed
by new tasks. They need to revise agreements with consultants and investigators to ensure they obtain all required information.
Co-promotion and co-development projects need updates to clarify responsibilities for collecting and reporting required information.
Reporting systems must provide HCPs who receive fees an opportunity to review and challenge payment reports. And internally,
pharma companies have to decide which unit assembles the data, who verifies it, and who signs off on its accuracy.
Improved tracking of payments will raise new issues. Corporate caps on annual compensation to an HCP for marketing activities,
for example, may generate conflicts between the marketing department that wants to use a prominent clinician as a spokesman,
and the research department planning to engage the same individual as an investigator. Reformers and regulators will be looking
hard for any sign of fraud or conflicts of interest.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com
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