Transparency is the buzzword in Washington these days. Soon after his swearing in on Jan. 20, 2009, President Barack Obama
issued a memorandum to all federal agencies calling for greater transparency in government actions, including rapid online
disclosure of information about government operations and decisions. Obama also called for high ethical standards for government
officials, a stance that helped derail the appointment of former Senator Tom Daschle as secretary of Health and Human Services
Transparency is a main theme in healthcare reform efforts, which emphasize the importance of public access to healthcare cost
and quality information. A serious problem with the nation's healthcare system is its lack of financial transparency, pointed
out Robert Reischauer, president of the Urban Institute, at a health policy meeting in February 2009. "Few people understand
what things cost or who pays the bill," he said.
Proposals to expand providers' adoption of health information technology (IT) and to fund comparative-effectiveness research
also foster transparency in healthcare. A wired healthcare system is needed to obtain information about provider practices,
costs and quality, and for communicating findings to the public. Objective comparisons of treatment options can supplement
the basic safety and efficacy information that manufacturers develop to gain the US Food and Drug Administration's market
approval for a product.
In Washington This Month
More drug disclosure
Pharmaceutical companies are all too familiar with transparency requirements involving drug research, production, and marketing.
Government agencies and consumer groups continually disseminate information about drug prices and coverage to curb inappropriate
use of medicines and to direct patients toward cost-effective treatments. Manufacturers face a growing range of state and
federal requirements for disclosing payments to researchers and medical professionals, and Congress is seeking full reporting
of industry–practitioner relationships to uncover conflicts of interest and discourage marketing of products for unapproved
Disclosure is a prominent theme in the FDA Amendments Act of 2007 (FDAAA), which expands manufacturer disclosure of clinical-research
activity, research study results, and drug-safety information. One objective of FDAAA is to inform the public quickly about
potential drug risks and adverse events by posting safety information early.
In addition, FDA is issuing Early Communication notices about particularly important safety concerns that warrant immediate
attention from practitioners. In February 2009, the agency announced it was working with Eli Lilly (Indianapolis, IN) to evaluate
reports of serious bleeding associated with the sepsis treatment "Xigris" (drotrecogin). In January 2009, FDA issued notices
updating efforts to assess possible serious drug interactions with the blood thinner "Plavix" (clopidogrel) to evaluate evidence
linking asthma treatments to suicidality, and to examine how well certain statins lower cholesterol. The drug-safety transparency
program has raised questions, though, about how extensively FDA should assess preliminary reports about safety issues before
going public. The concern is that sounding false alarms may unnecessarily reduce prescribing and prompt patients to discontinue
A prominent thrust of the transparency campaign is public disclosure of drug-pricing data. Medicare and prescription-drug
plans are posting information about drug prices and rebates to help beneficiaries understand differences in plan coverage
and out-of-pocket costs. The scope of this information may expand as patient advocates seek detailed information about beneficiary
copays for high-priced biotechnological therapies and clear explanations of some drug plans' policies that require patients
to pay the difference between generic and brand-name drugs.
Pharmaceutical companies also must report pricing information to state governments eager to ensure that their Medicaid programs
pay the lowest rates. California, Maine, New Mexico, Texas, and Vermont have adopted laws that require manufacturers to submit
information about drugs sold in the state to facilitate the comparison of average manufacturer prices to Medicaid best prices.
Several states also want to know financial terms, discounts, and other arrangements between manufacturers and pharmacy benefit