FDA Approval of Generic Daraprim Demonstrates the Slowness of FDA Process
​[Thursday, March 5, 2020]
This week FDA approved the first generic drug version of Daraprim. This drug was made famous about 5 years ago when a company increased its price by 5000% almost overnight due to a manufacturing monopoly and the CEO of the company, Martin Shkreli, became the poster-boy of bad pricing and illegal business practices. The fact that it took 5 years for a generic version of even this drug to be approved by the FDA demonstrates that no matter how much public outcry there is for such practices, the FDA is unable to approve generic versions of such drugs rapidly. It’s hard to believe that industry did not want to jump to manufacture a financially lucrative small molecule, but many stepped back when they realized that FDA is not willing to consider alternative pathways to development for generic, rather than using conventional development pathways that allow several ways to legally and practically stifle competition. Although FDA has touted its efforts to increase generic competition, the reality is that based on FDA’s own list, currently there are 484 drugs used by the US patients which are sold by a single company despite having no patent protection or market exclusivity. All these drugs have the potential to be exploited financially by manufacturers of these products due to the monopoly of the single source. Since most of these drugs have several decades of market experience with well understood chemistry, one would expect that FDA would propose a new regulatory pathway to expedite approval of generic versions based in fewer data requirements and shorter review timeline. There is ample precedence of FDA’s ability to propose new rules and pathways to address emergency situations. Monopolized drugs have been called by FDA as an emergency, but the measures proposed have been cosmetic. FDA maintains a much-publicized list of drugs with no generic versions expecting that companies would explore them as business opportunities. FDA also publicizes every time a new generic is approved for a drug on its list and to take credit. However, the case of Daraprim demonstrate that FDA still hesitates to take meaningful steps to address this emergency. There is need for a new pathway for approval of generic versions of drugs with no competition despite there being no scientific or legal reason to do so. Without it, as we have seen the last 5 years, FDA’s list had the opposite effect from the intended. Instead of encouraging more companies to develop generic version, it acted as a reference list for using the monopoly for price gouging.