CCPM coalition members urge Congress to fix or drop the current biogenerics provision

Oct 27 2009

The Coalition for a Competitive Pharmaceutical Market (CCPM), its allied organizations, representing several hundred million Americans, join experts from the medical and research communities, economists and thought leaders appealing to Congress to fix the excessive 12-year market exclusivity and ever-greening provisions for biologics or drop it altogether.

“Our coalition members first called for legislation establishing a pathway for generic competition in the closed biologic marketplace,” said Annette Guarisco, CCPM Chairman. “But we would rather have the status quo than legislation that guarantees profits for a few at the expenses of the American public.”

In a letter to Senate Majority Leader Harry Reid and Speaker of the House Nancy Pelosi, advocacy, industry and labor groups urge lawmakers to resolve the current provision that will create an ineffective pathway to bringing biogenerics or biosimilars to patients and consumers. The letter, written on behalf of older Americans, workers, businesses, and industry stakeholders (pharmacies, generic manufacturers, biotech companies, health plans, and pharmacy benefit managers), implores Congress not to overlook the immediate opportunity to bend the long-term cost curve of health care through a workable pathway for biogenerics.

“We urge Congress to pay serious attention to the growing expert counsel regarding the cost containing value of biogenerics – as well as the risk to consumers and successful health care reform if the legislation is not done right,” said Guarisco. “A timely pathway for the approval of biogenerics or biosimilars is one of the few, if not the only, health care reform measure that has irrefutably demonstrated the potential to significantly constrain costs.”

This letter is just one example of interested stakeholders voicing concern over the current provisions. As indicated in the October 22 Time Magazine article, “How Drug Lobbyists Got Their Way on Health Care,” there is a lot of skepticism among the American public, pharmaceutical researchers, medical students, and industry economic experts about the results of BIO and PhRMA’s influence on the health care reform deal. Furthermore, there is widespread concern that the result will be a missed opportunity to impact the availability of biologic treatments for those who need them.

In addition, the October 15, 2009 New England Journal of Medicine article, “Balancing Innovation, Access and Profits – Market Exclusivity for Biologics,” reflects similar sentiments and highlights the shortcomings of biologics provisions. The article indicates that, as currently fashioned, the biosimilar legislation would have no value because it would create a pathway that would scarcely be used. The provision would allow for “ever-greening,” or for manufacturers to obtain an additional 12-year exclusivity period by making minor changes to the structure of an approved product. Furthermore, additional market exclusivity beyond the term of a patent would "direct scarce [research and development] dollars toward developing low-risk clinical and safety data for drug products with proven mechanisms of action rather than toward new inventions to address unmet medical needs.” Please visit www.BiogenericsGetTheFacts.org to view the CCPM statement outlining key points from the NEJM article.

“Finding the right balance between incentives for innovation and timely access to care means that Congress needs to fix or drop the current biogenerics provision,” continues Guarisco. “We call on Congress to take this opportunity to truly constrain costs to benefit all health care purchasers, and override the lobby of the big pharmaceutical and biotech companies.”