With Congress intensely focused on big decisions involving health reform legislation, it’s easy to miss other initiatives that are quietly moving through Congress which could make a major contribution to achieving the goals of health reform
One example is a measure offered by Rep. Morgan Griffith (R-VA) that would open the lines of communication between biopharmaceutical, medical device, and related companies and medical providers to make sure they are making decisions based upon the best available scientific data and studies.
When the Food and Drug Administration approves a drug or medical device, it spells out the “intended use” of the product and limits communications between producers and providers to that definition.
But, as in any scientific realm, when doctors use the products, they learn based upon their experience and evidence that the products may work better for their patients in different doses or even “off-label.” In some medical specialties, the off-label use may actually be the approved standard of care.
Biopharmaceutical companies regularly study and produce data describing these post-market uses, including their safety, efficacy, and cost-effectiveness. But they are prohibited by the FDA from discussing truthful, fact-based information with providers, in scientific meetings, in published studies, and other communications.
This barrier has major implications for the move toward new payment models for drugs—payment models that have the promise of reducing drug costs by targeting treatments to those most likely to respond positively to them. The industry needs new communications standards so companies can engage in these new payment models such as payment for outcomes.
Rep. Griffith points out in a letter to colleagues that there has been an influx of litigation in this space, with clear conflicts between the companies’ right to First Amendment protections in freedom of speech and FDA rules prohibiting communications beyond the approved “intended use.” He believes it’s up to Congress to establish clear parameters.
Rep. Griffith believes his amendment to the Food, Drug, and Cosmetic Act would “clarify the statue so this type of scientific exchange between medical product manufactures and health care decision-makers can occur.” He said this would “enable manufacturers to proactively discuss with health care providers information outside the scope of FDA-approved labeling.”
His initiative has broad support in the medical and payer communities, from associations of neurological surgeons, gastroenterologists, ophthalmologists, urologists, rheumatologists, and others as well as from hospitals, academic health care centers, health plans, biopharmaceutical and medical device manufacturers, and information technology companies.
“Meaningful, fact-based discussions between healthcare product manufacturers and the purchasers of their products will help drive the adoption of better and safer patient care,” according to a letter of support from the Healthcare Leadership Council, adding that “driving high-value healthcare must be a priority.”
Opening the lines of communications about what works in medicine is a crucial step in modernizing our health sector to become more efficient and cost effective. This initiative is a quiet step in the background that could lead to big leaps in payment reform and patient care.