FDA commissioner, Scott Gottlieb, has recently announced some new measures being taken to potentially slow the rise of prescription drug prices in the US. Although the FDA does not directly play a role in setting drug prices, Gottlieb believes the agency’s policies can improve competition in the market, which should indirectly affect the costs patients must pay to receive medications.
To introduce greater competition, Gottlieb’s new initiatives aim to encourage the development of generic versions of hard-to-make drugs, known as complex drugs. Complex drugs are high cost medications which are harder to replicate or “genericize” under traditional approaches. This could be because the active ingredient or sites of action are particularly complex, or because the therapeutic effect is delivered to a particular organ rather than the bloodstream, or because the drug-device combinations are especially complicated or multifaceted.
Due to this complexity, manufacturers face difficulties developing these products and demonstrating their efficacy as well as their bioequivalency to branded products. Unsurprisingly, therefore, drug companies are often hesitant to add a complex drug to their pipeline efforts, meaning that costly branded drugs are subject to no generic competition, even after their exclusivity period ends.
To address these issues, the FDA has released two draft guidance documents for industry and has scheduled a series of scientific workshops which will take place over the next year.
The two draft guidance documents provide information intended to assist companies with the Abbreviated New Drug Application (ANDA) process. The first document will advise companies on how to successfully create and submit their pre-ANDA meeting requests and materials. These pre-ANDA meetings are a vital part of drug development and approval as they allow for early communication between drug companies and the FDA. This ensures that both parties are on the same page regarding the company’s development efforts and the FDA’s prospective approval criteria.
The second guidance document will help drug companies determine if and when the submission of an ANDA for peptides would be appropriate. Peptides are a specific type of complex drugs which are made up of 40 or fewer amino acids. This guidance is particularly important because there are, currently, a number of drugs on the market which are peptides and which have no generic competition, despite the fact that their exclusivity period has ended.
The scientific workshops have been scheduled to help develop new analytical tools for demonstrating and analyzing both the efficacy of a product and its bioequivalency to a branded drug. According to Gottlieb’s blog post, “Some drugs lack generic competition because they cannot be measured through traditional in vivo bioequivalence methods and there’s no efficient and convincing bioequivalence test method available.” The scientific workshops will allow the FDA and key stakeholders to come together to discuss new tools and methods for counteracting this issue so that companies are not discouraged from developing complex drugs.
To learn more about the three initiatives described above, check out Gottlieb’s original blog post, published on October 2nd, 2017.