As Congress continues to work to answer the call for fundamental reform of our nation’s healthcare delivery system, a critical component of such reform must include the establishment of an abbreviated approval process for “follow-on biologic” drugs, a priority upon which innovators and generic manufacturers both agree.
As Congress continues to advance the issue, generic and brand-name companies alike are now planting their seeds in the emerging follow-on biologic market, and we must make every effort to support these initiatives with the best interest of the American people in mind. I believe it is of the utmost importance that Congress take proactive steps to enhance competition in the biologic drug market and ensure that patients have access to safe and effective drugs.
{mosads}Congress should give the FDA the authority to allow scientists to determine what information is necessary in order to make scientifically appropriate decisions with regard to approval of follow-on biologic drugs.
In 2007, global sales of biologic drugs reached $75 billion and current estimates suggest that over half of all drugs — both chemical and biologic in nature — will be biopharmaceutical products next year. Biologic drugs have provided some of the most promising benefits for a wide range of diseases, including anemia, hemophilia, cancer, diabetes, HIV, rheumatoid arthritis and other debilitating medical conditions that affect millions of Americans every day. The Promoting Innovation and Access to Life-Saving Medicine Act, which I have co-sponsored with the chairman of the Energy and Commerce Committee, Rep. Henry Waxman (D-Calif.), as well as chairman of the Subcommittee on Health, Rep. Frank Pallone Jr. (D-N.J.), seeks to strike an appropriate balance which will incentivize innovation in the rapidly growing sector of biologic drugs and ensure the safety and efficacy of these products for American consumers across the country.
Much of the focus of this legislation seeks to ensure that FDA is given the tools they need to ensure the safety and effectiveness of follow-on biologic drugs. While some legislative proposals introduced in the 1110th Congress and again this year seek to establish an unnecessarily lengthy, statute-based process for FDA approval of biosimilars, H.R. 1427 gives FDA the scientific discretion to hold these products to the same high standard for approval to which original biologic drugs are held while giving the agency the flexibility it needs as the agency’s understanding of biologic drugs is enhanced through new sciences and technologies not available in the marketplace today.
While biologics are highly effective, they often cost on average 22 times more per daily dose than chemical drugs, the most expensive of which cost well over $100,000 per year. The extreme cost of these therapies, combined with rapid increases in biologic drug utilization in the U.S., only underscores the need for this legislation as the strain on family budgets and state and federal programs continues to grow.
I believe in order to promote fair competition and thus drive innovation in the U.S., an appropriate balance must be struck in determining the appropriate length of market exclusivity for innovator products — that is, the period of time in which a competing product is precluded from coming to market. A number of recent studies have been conducted to address this fundamental question, but market-based factors such as cost of capital assumptions, profitability projections and the like have resulted in differing recommendations for the appropriate period of market exclusivity protection to allow brand-name manufacturers to recoup their significant initial outlays expended in drug development. I certainly recognize the importance of providing an adequate period of time to protect the incentive to innovate new drugs, and I believe through strong protections under the patent system in conjunction with an appropriate period of innovator market exclusivity, we can achieve a balance upon which everyone —both manufacturers, patients, providers and payers alike — can benefit through spurring innovation, enhancing competition and ensuring continued access to these life-saving drugs.
The Promoting Innovation and Access to Life-Saving Medicine Act takes a significant step forward in enhancing access to these life-saving therapies and is widely supported among members of the healthcare community. This legislation is about promoting competition, driving innovation and ensuring our constituents have access to the therapies they need. I ask all of my colleagues to join me in supporting this effort.
Deal is a member of the House Energy and Commerce Committee.