By Sara W. Koblitz –
Pushing forward with his commitment to accessibility, Commissioner Gottlieb recently announced further efforts to encourage generic approval. In another FDA Voice Blog Post, Dr. Gottlieb reiterated the agency’s renewed focus on drug pricing and competition and announced new measures to aid in the development of generic versions of “complex drugs.”
Complex drugs, like drug-device combinations or injectable drugs or other forms of complex active ingredients or sites of action, are generally high-cost medicines that are not frequent targets of generic development regardless of patent or exclusivity status. These drugs are often difficult to replicate and have murkier pathways to approval; demonstrating bioequivalence may be challenging when the active ingredient cannot be easily measured in the blood or the therapeutic effect is not delivered systemically. This complexity delays and deters generic development, allowing NDA holders to charge a premium for the brand version.
In an effort to assist potential ANDA applicants for complex products, FDA issued a new draft guidance this week providing information to help sponsors request and conduct product development meetings, pre-submission meetings, and mid-cycle review meetings – all of these are commitments that FDA agreed to in the GDUFA II negotiations. These tools are similar to those available for NDAs under PDUFA, and the initiative is intended to enhance communication between generic drug applicants and FDA early in the development process to allow for more efficient development, review, and approval.
FDA issued an additional draft guidance this week to assist applicants submitting an ANDA for synthetic peptide drug product referring to an rDNA peptide – specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide. According to this guidance, FDA believes that peptide synthesis and characterization technology now allows an ANDA applicant to demonstrate that the active ingredient in a generic synthetic peptide drug product is the “same” as the active ingredient in an rDNA peptide based largely on impurity profile comparisons. Because there are quite a few branded medicines without exclusivity that are peptides (compounds made up of 40 or fewer amino acids), this guidance could allow new competition where previously no generic development existed.
FDA is taking advantage of scientific development to expedite drug access and competition. As part of this initiative, Dr. Gottlieb states that FDA’s generic drug regulatory science program will work to develop more tools, methods, and efficient alternatives to clinical endpoint testing in the next year to further enable competition. FDA will continue to hold scientific workshops identifying opportunities for development for both product-specific guidance documents and new analytical tools.
This FDA Voice post is yet another in a series emphasizing FDA’s push towards affordable access to medicines. The enthusiasm with which this administration is addressing drug pricing and competition is not surprising, given Dr. Gottlieb’s extensive economic and health policy background, but it is certainly untraditional with respect to the role FDA has traditionally played in drug pricing. It’s certainly interesting to watch the agency’s “public health” mission expanding in front of our eyes, and we’re looking forward to seeing what else is in the pipeline!
FDA’s Getting a Complex
By Sara W. Koblitz –