Groups Want ‘Deemed License’ Policy Changes

Several stakeholders are asking FDA to make substantive changes to a draft guidance on implementing the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council say that although they agree with many aspects of the draft guidance, they are “concerned that FDA’s proposed policy with respect to pending applications under Section 505 that are not approved by 3/23/20 is contrary to the express language of the BPCIA and will unnecessarily complicate and delay the approval of lower-cost versions of biological medicines that currently are regulated under the Federal Food, Drug, and Cosmetic Act. Because FDA’s proposed policy will impair patient access to affordable alternatives to these important brand name biologics contrary to congressional intent, GPhA respectfully requests that FDA amend its policy to facilitate a streamlined transition for both approved and pending applications.”

The trade groups ask the agency to amend its proposed policy by adopting one that complies with these principles: 

•          pending applications submitted under Section 505 for a protein product subject to the transition provisions will, on 3/23/20, be deemed to be pending applications submitted under Section 351(a) or 351(k) of the Public Health Services Act, as appropriate;
•         FDA will review the re-designated applications based upon the data and information already submitted and will rely and build upon the review already completed by the applicable review division;
•         to meet any new or different statutory requirements for biologics regulated under the PHS Act, applicants will be permitted to amend their pending 351(a) or 351(k) application after the re-designation;
•         for purposes of establishing a goal date under the Biosimilar User Fee Act or PDUFA, as applicable, the submission and filing dates of the 351(a) or 351(k) application will be based upon the submission and filing dates of the original Section 505 application; and
•          any application fees paid with the original application under Section 505 will be credited toward the application fee required for a 351(a) or 351(k) application.

 The groups conclude that they support the agency’s proposed policy regarding approved biological products subject to the BPCIA transition provision, including FDA’s position that such products are not eligible for four- and 12-year exclusivity under the BPCIA. But they say that they believe the proposed policy regarding pending applications is inconsistent with the plain language of the BPCIA and should be amended.

“By creating a regulatory ‘dead zone’ for pending applications,” the letter says, “FDA’s proposed policy would have a ‘significant impact’ on ongoing development programs for proposed protein products that, in turn, will impede patient access to affordable alternatives to these important brand name biologics, contrary to congressional intent. Instead of adopting a policy that, by the agency’s own admission, severely impacts the marketplace, FDA should implement policies that ‘ensure that the transition from one jurisdictional category to another would take place with minimal disruption to the marketplace and minimal prejudice to the firms subject to the move.”

Pharmaceutical Research and Manufacturers of America (PhRMA) says it has serious concerns about the draft guidance because “we believe that the agency is misinterpreting the BPCIA in a manner that would harm the incentives of sponsors to innovate and bring new treatments to patients. We strongly recommend that FDA reconsider its proposed interpretation of the transition provisions and substantially revise the draft guidance. FDA should do so on an expedited basis and well in advance of 3/23/20, because clear and timely guidance is critical for sponsors of biological products that fall within a product class subject to the transition provisions….”

Three areas of concern listed by PhRMA are: 

•          the draft guidance interpretation of statutory regulatory exclusivity requirements, and particularly FDA’s proposal to extinguish unexpired Waxman-Hatch and pediatric exclusivity for transitioning NDAs and also to deny these applications any reference product exclusivity … is inconsistent with the BPCIA and would significantly harm incentives for medical innovation;
•          the FDA proposal that NDAs pending on 3/23/20, including NDAs that have been tentatively approved, would not be finally approved and would need to be withdrawn and resubmitted under the Public Health Services Act is contrary to the plain language of the BPCIA; and
•          the draft guidance leaves unanswered critical questions about implementation of the transition provisions, including whether applications under Section 505 of the Federal Food, Drug, and Cosmetics Act will be deemed licensed under Section 351(a) or Section 351(k) of the Public Health Services Act, whether FDA intends to list transition biological products in the Purple Book, how FDA proposes to treat transition biological products for which there was a determination of therapeutic equivalence in the Orange Book, what technical application rules will apply to transition biological products, and what nonproprietary naming convention will apply to transition biological products, among other issues.

Finally, writing on behalf of several clients, Hyman, Phelps & McNamara says that the draft includes an “unnecessarily restrictive proposal for handling applications for biological products submitted under Section 505 of the Federal Food, Drug, and Cosmetic Act that have been submitted but not yet approved as of 3/23/20.” The letter says that the agency recognizes that its interpretation of the BPCIA will have a significant impact on development programs for protein products not able to gain approval by 3/23/20, but its recommendations to mitigate the impact are unrealistic and overly burdensome.