FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

April 3, 2024By Sara W. Koblitz

Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress.  This year is no different, and in fact some of the requests on this year’s list are repeat offenders from last year’s.  And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides important insight for industry to see where FDA thinks it might need congressional assistance to “better support Agency efforts to protect American consumers and patients.”  Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list.

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market.  In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.  This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms.  “FDA believes this change would effectuate timelier and more cost-efficient generic drug development . . . .”  Additionally, FDA moves into the biologics world, seeking to facilitate follow-on competition in that market by asking Congress to do away with the line between interchangeable biosimilars and other biosimilars; eliminating that distinction would allow for substitution of biosimilars (rather than only interchangeable biosimilars) thereby eliminating an obstacle to follow-on biologic access.  Finally, FDA asks Congress to amend to FDCA § 505(j) to address the submission and review of drug-device combination product ANDAs, as well as drug products submitted in an ANDA that are used with devices.  While it is not in question that FDA has the authority to approve combination product ANDAs, FDA seeks amendments to clarify that FDA can request and review data for such applications, that certain differences between the device constituent parts of the reference listed drug (RLD) and the proposed generic are permissible, and that differences in labeling between the RLD and the proposed generic as a result of permissible differences in the device are also permissible.

In the second category—limiting blockades to marketing—are efforts to limit blocking exclusivities and induced infringement liability.  First, FDA proposes to amend three-year exclusivity such that exclusivity is awarded only where the new drug applicant is actually seeking exclusivity and where the data supporting exclusivity actually demonstrates the hypothesized effect of the drug; this approach would prevent information on new safety risks from blocking competition.  Second, FDA proposes to amend the 180-day forfeiture provisions to address exclusivity parking by adding a 75-day failure to market period triggered by resolution of patent litigation without a finding or infringement or invalidity if there is no settlement agreement limiting the ability to market.  If a settlement agreement does limit ability to market until a certain date, that date would trigger a 75-day failure to market period.  Finally, in response to the GSK and Teva litigation, FDA continues to ask for a legislative fix.  Specifically, FDA asks to add a “safe harbor” from patent infringement liability for applicants for generic applicants marketing with a “skinny label” due to Agency concern that induced infringement litigation threats will impact the “timely availability” of generic drugs.  We note though that the proposed “safe harbor” isn’t exactly a “safe harbor” that would alleviate concerns of allegations of induced infringement arising from skinny labels; instead, it would only limit the use of certain claims from evidence of induced infringement and thus may not have the intended effect.

In addition to those initiatives relating to generic competition, the FY25 Legislative Proposals is filled with requests for other legislative authority.  Of particular interest to this blogger, FDA includes several initiatives related to animal drugs.  Specifically, FDA seeks a “targeted statutory provision for FDA-regulated biologic products for animals” so that more of these products can become approved, as the Agency estimates that over 95% of such products are not approved right now.  FDA also asks to amend the FDC Act to require labeling updates for new safety information for animal drugs, to allow for REMS for animal drugs, to require postmarketing studies for animal drugs to assess known or potential risks, and to prevent diversion of animal drugs.  FDA also asks for recall authority over drugs—both human and animal—to remove violative drug products from market “more quickly”.  There are a significant number of additional initiatives the Agency requests with sections dedicated to “Enhancing Data, Information, and Postmarket Safety;” “Addressing Medical Product Shortages and Supply Resiliency;” “Modernizing Foods Authority;” and “Other.”  FDA has a lot of wants, and it has seized the opportunity to ask for what it wants, what it really really wants.