Prescription-drug policy: Don't give the FDA power over standards for biosimilar medicine
While Kentucky Senator and Majority Leader Mitch McConnell’s proposal to raise the legal age of purchasing tobacco has received a large share of attention regarding the suite of healthcare proposals currently being considered in the U.S. Senate, other issues affecting cost and access to health care – including for prescription drugs – must be carefully considered by the deliberative body.
Washington needs to continue progress made in recent decades with passage of legislation tempering the market power of pharmaceutical companies holding virtual monopolies for the long lives of their drug patents with policies that increase transparency regarding how drug prices are determined and promote competition which incentivize cheaper generics and biosimilars.
(Generics are identical replicas with the sane chemical substance as the brand drug; biosimilars aren’t exactly the same but have no meaningful clinical differences.)
Joseph R. Antos, Ph.D., with the American Enterprise Institute, noted in testimony before the House Committee on Ways and Means earlier this year that such tension will always exist “between promoting pharmaceutical innovation and maintaining access to affordable, safe and effective medical treatments.”
However, as Antos adds, the same protection that gives significant market power to the innovator to set prices – usually much-higher ones on brand name drugs rather than generic ones – also “slows the entry of competing products that can put downward pressure on prices.”
The way to change this is not to move away from reasonable transparency and certainty regarding the prescription drug marketplace such as proposed by a couple of proposals moving through the Senate.
First, Section 207, which is buried within the Senate’s Lower Health Care Costs Act (S. 1895), proposes eliminating the statutory requirement that biologic drug manufacturers must adhere to regarding transparent public quality standards as established by U.S. Pharmacopeia (USP), a nongovernmental agency.
In addition, the bill would hand over authority for approving quality standards to the Food and Drug Administration, thus expanding the authority of an agency which already has a broad set of responsibilities and an increasingly limited – and stretched – budget to meet them.
Such an approach would cause great confusion and uncertainty with doctors and pharmacists who rely on the independent agency’s analyses to ensure medicines given to patients contain the correct ingredients with the strength, quality and purity indicated on the label.
Groups from across the political spectrum oppose this provision.
Left-leaning groups view the measure as moving away from the accountability needed to ensure patient safety and in the direction of industry self-regulation, exposing consumers to unnecessary dangers.
“If section 207 is adopted, public quality standards would not be required for a broad range of biologic medicines, including insulin, jeopardizing medicine uniformity and quality, and threatening the health of patients who have a wide range of conditions, including diabetes, cancer, hepatitis, and autoimmune disorders,” Public Citizen claimed in a letter to Congress. “It also would remove independent scientific experts from the standards process and allow quality standards for these vital biologic medicines to be kept secret by the government.”
Like so many health-care policies, Section 207 seems well-intentioned with supporters introducing the proposal as a way of removing perceived regulatory barriers for biologics.
However, as noted in a letter signed by a coalition of conservative and free-market groups, allowing the USP to continue transparently establishing quality standards encourages rather than impedes competition between pharmaceutical companies and manufacturers of generic and biosimilar drugs “by setting public standards through a transparent, scientifically informed process, which are used as a benchmark for development and production by competitors seeking to expand consumer choice and access to life-saving medicines.”
The letter also notes that these standards for biologics, which have been in place for decades in Europe -with its robust biosimilars market are developed using the private-sector expertise of medical and scientific researchers and occur “at no cost to the taxpayers” as USP is a self-funded nongovernmental nonprofit agency.
Not only is this a solution in search of a problem, it would create more problems and perhaps lower the nation’s overall standards of prescription drug quality.
No doubt, the Majority Leader will note that both the political left and right oppose Section 207. And both are right.
Editor’s note: Tomorrow, we’ll consider another bill which proposes getting rid of “pay for delay.”