Déjà vu! Senators Follow House Colleagues in Making BPCIA Exclusivity Clarifications; New Study Suggests Benefits of Longer Drug Exclusivity Period

January 11, 2011

By Kurt R. Karst –      

In a January 7th letter sent to FDA Commissioner Margaret Hamburg, a group of four U.S. Senators take exception to FDA’s recent characterization of the 12-year exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as a period of “market exclusivity” instead of “data exclusivity.”  The Senators also take the opportunity to remind FDA that the BPCIA allows for a separate period of exclusivity for new biological products. 

The letter, signed by Senators Kay Hagan (D-NC), Orrin Hatch (R-UT), Michael Enzi (R-WY), and John Kerry (D-MA), raises the same two issues some House members – the principal authors of the BPCIA – raised in a December 2010 letter to FDA.  As we previously reported, the House letter notes “significant and critical differences between the two types of exclusivity” (i.e., data and market exclusivity) and says that while so-called “evergreening” is not permitted under the BPCIA, “if a ‘next generation’ product is approved by the FDA as a new product (significant changes in safety, purity, or potency) then that new biologic will receive its own 12-year period of data exclusivity.” 

The January 7th Senate letter, which similarly seeks to clarify the exclusivity vernacular and to lay an early foundation for what are certain to be future battles over the availability and scope of the exclusivity period created by the BPCIA, states:

The [BPCIA] does not provide market exclusivity for innovator products.  It provides data exclusivity, which prohibits FDA from allowing another manufacturer of a highly similar biologic to rely on the Agency's prior finding of safety, purity and potency for the innovator product for a limited period of time.  It does not prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a full biologics license application rather than an abbreviated application that relies on the prior approval of a reference product. . . . 

At the same time, the Act provides incentives for innovators to research and develop new treatments for patients.  If a manufacturer modifies an approved product to produce a change in safety, purity or potency, the modified product is rightly considered a new product.  It will be protected by the data exclusivity provisions afforded new products. Exclusivity on the first generation product will expire as scheduled.

For those of you who are interested in a further discussion of data versus market exclusivity, which folks have tussled over for years, our friend Steve Grossman over at FDA Matters had a nice post on the topic last year in the context of the BPCIA.

The BPCIA’s 12-year exclusivity period (which can be extended to 12.5 years with pediatric exclusivity) has been criticized from several quarters.  Late in 2010, Senator Bernie Sanders (I-VT) even said that the BPCIA’s 12-year exclusivity provisions create an ethical “defect” and should be changed.  (See our previous post here.) 

Taking a somewhat different position than Sen. Sanders on the topic of exclusivity are the authors of a recent article published in Health Affairs, titled “The Benefits From Giving Makers of Conventional ‘Small Molecule’ Drugs Longer Exclusivity Over Clinical Trial Data.”  The article details the results of a study (apparently the first of its kind, and funded by INTERPAT, “an association of research-based pharmaceutical companies,” and by the National Institute on Aging) intended to calculate the financial and social costs of limiting access to trial data.  The article focuses on small molecule drugs, which are subject to the Hatch-Waxman Amendment’s 5-year new chemical entity and 3-year new clinical investigation exclusivities, but asks whether a longer period of exclusivity, like the BPCIA’s 12-year period, would benefit innovation, population longevity, and social welfare.  Guess what?  According to the authors, extending data exclusivity to 12 years would (1) “increase lifetime drug revenues by 5 percent, on average;” (2) “result in 228 extra drug approvals between 2020 and 2060, relative to the number of approvals that we project under the current Hatch-Waxman data exclusivity provisions;” and (3) for people turning 55 in 2060, they “can expect increased life expectancy of 1.44 years as opposed to 1.30 years under the status quo.”