Recently, the FDA made a decision to provide expedited ANDA (Abbreviated New Drug Application) review for generics without existing competition and simultaneously published a list of associated branded products. Just a week prior, the FDA announced an initiative that will be of more importance - a push to reduce potential anti-competitive actions limiting the ability to file, produce or market generic drugs. In a recent blog post, the Commissioner of the FDA, Scott Gottlieb, stated the FDA will hold a public meeting July 18, 2017 to identify ways FDA policies are limiting access to generic pharmaceutical products.
On the surface, this is an attempt to encourage competition – especially when undertaken as a joint effort between the FDA and the FTC. Generic competition is legal once the branded product exclusivity period is complete, and therefore branded manufacturers must comply with these rules. However, branded manufacturers are well within right to protect their product and use every possible avenue afforded within the regulations to do so. At the same time, for the sale of patient access to potentially life-saving drugs, the FDA is obligated to review its own policies and ensure they are best suited to today’s market and current competitive dynamic.
This effort must be undertaken cautiously. The FDA must ensure generics can be developed and marketed in a safe and timely manner regardless of the changes enacted.
Commissioner Gottlieb specific identifies two areas of interest in his post:
- The statutory requirement for a single Risk Evaluation and Mitigation System (REMS) program across all versions – branded or generic – of a product
- Limiting the availability of samples of the reference product required for comparative testing
This ability for the manufacturer to use existing rules and regulations to limit access to their product, or delay integration and/or deployment of a codified REMS system, puts them more in control of when and how a generic drug can enter into competition. However, these rules, especially REMS program requirements, are in place for a reason. REMS programs are a significant and important component of ensuring drug safety, and their integrity must be maintained. Should the execution requirements change, it must be done so responsibly. All attempts to force manufacturers to offer salable quantities to the generic manufactures must be done in a way that does not put commercially available quantities at risk.
Encouraging competition is paramount in a free market, though patients’ health, wellness and safety must remain the priority. Otherwise, we are putting patients at risk all for the sake of slightly more competition and likely only in niche markets. We look forward to seeing the outcome of the public forum on July 18th and hope any future removal of these barriers to competition is done in a way that ensures the continued safe and scientific approach to drug application, testing, and approval, and are not the subject of hasty changes for the sake of creating increased competition.