Public Meeting on Balance of Hatch-Waxman – Some Observations

On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”.  The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”

While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar.  Issues relative to increasing competition through expedited review of generics where there are no or 3 or fewer approved ANDA and which is already a part of the OGD program as defined in MaPP 5240.3 (see previous post here) was applauded by most presenters.  Another issue discussed to improve competition is for FTC and FDA’s continued attention to pay-for-delay agreements between brand and generic manufacturers. These agreements are tricky and must be evaluated on a case-by-case basis because in some instances they actually allow a generic version of the branded product to come to market prior to patent expiration.  The question is whether the deal is being done to continue the monopoly of the brand, or if the patent in question is actually strong and the brand and generic company decide to avoid costly litigation by settlement or whether the brand is simply paying the generic applicant to keep its product off the market.

REMS and restricted distribution systems were other issues that seemed to crop up in most presentations.  And while most observers acknowledged the legislative efforts to try to rectify the abuse in preventing potential ANDA sponsors access to samples for bioequivalence testing, the question as to how and if there are any constitutional issues associated with requiring innovator firms to sell their products to generic manufacturers for that purpose, is going to be an issue that has to be ultimately decided in the courts.  One Pharma representative cited the fact that the Agency guidance on the issue of obtaining drug samples for REMS products has not been finalized.  I question whether the fact that the draft guidance has not been finalized has any real bearing on the protection of patients enrolled in bioequivalences studies where the brand product is subject to a REMs especially with the oversight of the FDA relative to the protocol for conducting the bioequivalence testing and the assurance of the safety of the patient.

Another hot topic seemed to be the issue of product hopping or evergreening.  That is the process of introducing a new formulation (extended-or delayed release or new combination of two existing approved or approved and OTC products, etc.) close to the expiration of patents or exclusivity protection of the original brand product.  The FDA asked most presenters what the FDA can really do about it especially when the introduction of some of these new products might improve patient compliance? Very little was offered as how to fix the problem.  Dr. Kathleen Uhl asked one presenter that very questions but said other “than you don’t want us to do it what are your suggestions,” but there was no substantive response.  The patients could still obtain prescriptions for the two separate drugs or an immediate release product, but this assumes the innovator does not remove its original product from the market at the time of approval of the new formulation or that generics are available for the single entity products.  Increased compliance with drug regimens and patient convenience is obviously a benefit to the patient even at a higher cost because the most expensive drugs that a patient can be prescribed are the ones they do not take!

One presenter discussed the increased cost of “DESI” drugs when the first NDA is approved for a product that has been marketed as an unapproved drug for years and suggested that the FDA should lengthen the time between first approval and when the FDA takes action to remove the other “DESI” marketed unapproved products from the market to 18-24 months instead of the 12 months, as stated in the existing Compliance Policy Guide.  The presenter noted several examples of where prices had spiked once the FDA approval occurred and the Agency forced other products off the market.  This has always been a bone of contention of mine and not the price issue, but the fact that many of these products have been marketed without approval for over 50 years and FDA has made its intentions know that firms should be seeking approval of these products over the last 15-20 years if they wanted to continue marketing them.   Firms have had plenty of time to seek FDA approval and in some cases, they have even had time to submit and obtain approval of generic versions of the products, yet, as the years have gone by many firms have decided not to seek product approval, but continue to complain about FDA enforcement actions and the impact on the drug price when those firms that spend the money to obtain FDA approval. Begin marketing and their unapproved products must come off the market.

While there were many issues discussed at the FDA open meeting on this issue that are too numerous to point out, the issue of biosimilar naming certainly deserves a shout out.  Speakers that represented the biopharmaceutical industry felt that the 4-letter suffix was essential to be able to track and identify any patient safety issues. Those that represented payors and biosimilar firms lobbied the FDA to reverse its position on the use of the suffix to differentiate products.  You know the story here probably better than I so let’s just leave it at that before my blood starts to boil.

SO please review the transcript and presentations that hit the docket because many speakers when queried about a specific position on an issue mostly said their organization would have more specifics in the detailed comments to the docket and the meeting.  Let’s hope their suggestions are more definitive that the basic lack of specifics presented at the meeting.