Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation

By Kevin E. Noonan --

Members of Congress (Rep. Anna G. Eshoo (D-CA) (at right), Rep. Jan Inslee (D-WA), and Rep. Joe Barton (R-TX)) who sponsored the follow-on biologics portion of the comprehensive health care reform bill past year (Patient Protection and Affordable Care Act (H.R. 3590, now P.L. 111-148)) have sent a letter to the Food and Drug Administration, purportedly to explain the "legislative intent" of the data exclusivity provisions of the bill.

Those provisions read as follows:

SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGI CAL PRODUCTS.

(a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO- SIMILAR OR INTERCHANGEABLE.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended—

(7) EXCLUSIVITY FOR REFERENCE PRODUCT.—

''(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).

This portion of the bill would preclude a biosimilar application from being approved "until the date that is 12 years after the date on which the reference product was first licensed."  This provision has been described by several commentators as providing a 12-year "market exclusivity" term for innovator biologic drugs.  Not so, say these MOCs; responding to the following question posed by the Agency in public hearings regarding implementation of the new law:

What factors should the agency consider in determining whether a modification to the structure of the licensed reference biological product results in a change in safety, purity, or potency, such that a subsequent Biologic License Application (BLA) may be eligible for a second 12-year period of marketing exclusivity?

Their letter states that P.L.111-148 does not provide a market exclusivity period.  Instead, the bill provides 12 years of data exclusivity.  The differences between these two types of exclusivity are "significant and critical," because the intent of these legislators was to "prohibit[] the FDA from allowing another manufacturer to rely on the data of an innovator to support approval of another product."  The law was not intended to "prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a similar of competitive product."  This interpretation would encourage biologic drug competitors (presumably using the innovator's FDA submission as a roadmap) to submit their own data in support of an independent biologic license application (BLA) pursuant to Sec. 351 of the Public Health Service Act.

The letter also emphasizes that the bill prohibits "evergreening" by innovators, specifically that "no product, under any circumstances, can be granted 'bonus' years of data exclusivity for mere improvements on a product."  New products, termed "next generation" by the letter's signatories, are not within the definition of evergreening -- such a new product (having "significant changes in safety, purity or potency") is considered a "new biologic [that] will receive its own 12-year period of data exclusivity" (emphasis in original).  However the letter positively asserts that while its authors "care deeply about patient access to biologics," they "also care about the advancement of science and our ability to treat the most complex diseases."  Thus, they warn that "[a]ny proposal to limit the definition of a 'new' product, and thus one which is entitled to its own period of data exclusivity has the potential to stifle innovation and negatively impact patient care," which they oppose.

While certain to be helpful in guiding the agency on interpreting the statute according to Congressional intent, the letter is not in any way binding on how the Agency decides to promote its regulations.  There is a long tradition of skepticism by legal scholars and judges about the validity of any "intent" asserted for Congress in passing legislation.  And executive agencies have the capacity (indeed, the duty) to interpret their enabling statutes and are granted (by courts) substantial deference in these determinations.  So while the letter from these members of Congress is certainly deserving of consideration, stakeholders and their opinions, as well as Agency expertise, are likely to play an even more important role in shaping the eventual contours of follow-on biologic drug policy.

Comments

[Kevin Outterson]

BIO asked for and got a similar letter from 4 senators: Hatch, Kerry, Hagan and Enzi.

The statute does not say what form the 12 years of exclusivity takes. If the FDA sticks with market exclusivity, then the molecule is protected for 12 years, but the test data can be made public. I'd like to hear what other people think the practical effects would be.

[Kevin E. Noonan]

Thanks, Kevin. We'll see if we can get that letter.