Improving Generic Drug Approval at the FDA

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about saving lives by getting new drugs to patients more quickly.” But generics are the drugs that many of us take every day. Generic drugs’ ease of entry into the market impacts whether everyday Americans can afford health insurance and access healthcare. Better recognition of these benefits combined with insurer buy-in to the Food and Drug Administration’s (“FDA”) generic approval program has the potential to improve health while reducing systemic costs. This Note proposes three changes to the current approval process for generic drugs at FDA. First, the FDA should conduct a regular study to identify drugs that feature the biggest negative medication adherence impact.3 Second, the FDA should allow insurers to sponsor generic approval for those drugs. Third, the FDA should be required to engage healthcare stakeholders beyond generic drug makers and manufacturers when it negotiates generic drug approval funding with industry