Jill Wechsler

Expanded use of health information technology by providers promises to uncover information on provider quality and costs and communicate it to the public. And objective comparisons of treatment effects would supplement the basic safety and efficacy data developed by sponsors to support market approval of products by the FDA.

Pharmaceutical companies are all too familiar with transparency requirements. The FDA Amendments Act expands reporting of clinical research programs, research study results, and drug safety information. Disclosure of company payments to researchers and doctors is on the rise, along with public posting of drug costs and coverage.

A prominent component of the transparency movement is to broaden disclosure of financial interests of investigators involved in clinical research on new drugs and medical products. The aim is to prevent researchers from fudging the data or skewing results in order to bring new treatments to market—and benefit the investigator financially in the process.

To this end, FDA and the National Institutes of Health (NIH) require investigators to report significant payments from sponsors, proprietary interests in a test product, and equity in a sponsor's company. But reformers are pressing to expand disclosure of manufacturer payments to researchers in order to minimize the role of money in shaping new drug development and utilization.

The Health and Human Services' Office of the Inspectors General (OIG) issued a report in January 2009¹ recommending that sponsors of clinical trials disclose investigator financial information to FDA before studies begin, instead of when the company files a new drug application (NDA), as now required by FDA. The change would allow FDA inspectors to review financial reports when they inspect clinical sites and would increase reporting rates by clinicians, which the OIG says is way too low.

FDA currently advises sponsors to collect financial information whenever they engage an investigator during the research process to be sure there will be no serious conflicts-of-interest that could compromise study outcomes. But the OIG found that little financial data was listed in some 100 NDAs filed in 2007, and many of the applications contained no investigator reports.

Sponsors object that earlier filing would bring in reports on many investigators involved in studies that turn out to provide little support for product efficacy. And FDA fears being inundated by financial records that turn out to be unimportant.

NIH also has been under fire from Congress for failing to adequately police financial conflicts-of-interest among academic researchers receiving federal grants. NIH requires grantees to report payments from drug companies that exceed $10,000, but investigators with Sen. Charles Grassley (R-IA), ranking Republican on the Senate Finance Committee, have uncovered prominent academics who fail to report millions in payments. This includes a number of psychiatrists involved in testing and presenting on widely used antidepressants.

NIH officials agree more needs to be done to police such activity, but they don't want to start examining the tax returns of thousands of researchers.

Payments and prices

Transparency requirements also are expanding pharma disclosure of payments and gifts to all health professionals. States are passing laws that require manufacturers to disclose payments and gifts to health care professionals, as seen in Minnesota, Vermont, West Virginia, Maine, and most recently in Massachusetts.

A long list of states is considering similar statutes, including California, Texas, Illinois, and New York. These laws generally seek data on fees, gifts, and educational grants to health providers and organizations, but policies vary as to which expenditures have to be disclosed and when.

Manufacturers also have to report a range of pricing information to state governments eager to ensure that their Medicaid programs get best prices. California, Maine, New Mexico, Texas, and Vermont have adopted laws that require companies to submit information on drugs sold in the state to facilitate comparison of average manufacturer prices (AMPs) and to Medicaid rates. And Medicare is posting information on drug prices and rebates on its Web site to help beneficiaries understand differences in plan coverage and out-of-pocket costs.