By Kevin E. Noonan --
Members of Congress, from both houses, have let the Food and Drug Administration know their views on the distinction between "data exclusivity" and "market exclusivity" under the follow-on biologics pathway provisions of the Patient Protection and Affordable Care Act (P.L. 111-148, § 351(k) of the Public Health Service Act, codified at 42 U.S.C. § 262(k))(see "Senators Let FDA Know Their Intent Regarding Data Exclusivity Provisions of PPACA" and "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation").
Now it is the generics industry and its supporters who have sent a letter to Commissioner Margaret Hamburg last Thursday. The letter was signed by several generic drug manufacturers (including Hospira, Medco, Mementa Pharmaceuticals, Mylan Labs, Teva Pharmaceuticals, and Watson Pharmaceuticals), healthcare providers (including Humana, Aertna, and CVS Caremark), and industry and patient groups (AARP, the Generic Pharmaceutical Association, and Pharmaceutical Care Management Association). Their letter recognizes overlapping intervals of market and data exclusivity, pointing out that a follow-on biologic drug applicant:
• Must wait four years after a reference brand product is first approved under a Biologics License Application (See Section 351(k)(7)(B)) to submit an application; and
• Must wait a period of 12 years before a biosimilar or interchangeable product can be approved under Section 351(k) that references a reference brand biologic product (See Section 351(k)(7)(A).
This results, the authors contend, in four years of market exclusivity and data exclusivity, followed by eight years of market exclusivity. This is contrary to the understanding of the legislators, who contend that it is data exclusivity, not market exclusivity, that exists during the last eight years of the exclusivity term, since after the first four years, a follow-on biologic drug maker could submit its own data and be approved (provided there are no patent infringement issues that might keep the follow-on biologic drug maker from the marketplace).
In addition to this different understanding of the exclusivity provisions of the law, the letter writers take the opportunity to remind the Commissioner that they opposed the 12-year data exclusivity term when the law was still being debated as a bill:
During the legislative debate, we strongly opposed the 12-year period in these provisions because it restricts competition, delays entry of affordable medicines, and discourages real and important innovation of new cures. During the legislative debate, we strongly opposed the 12-year period in these provisions because it restricts competition, delays entry of affordable medicines, and discourages real and important innovation of new cures.
And the letter warns of the consequences of the Agency implementing the law with regulations that "prevent biosimilar filings for 12 years:"
[C]onsumers will have to endure an unknown period of delay of FDA review and approval that could stretch far beyond the 12-year total that was set in the legislation.
Accordingly, the authors "concur with the FDA's initial understanding of the provision and ask that the FDA implement the law as passed."