A Call for Transparency in Research and Marketing - Pharmaceutical Technology

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A Call for Transparency in Research and Marketing
Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.


Pharmaceutical Technology
Volume 33, Issue 3, pp. 40-50


Jill Wechsler
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 (HHS).

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.


In Washington This Month
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.

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 uses.

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 treatment.

Price reporting

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 managers.


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