The number of theories out there on how to fix the American prescription drug system is enough to maybe take a crack at actually fixing it, but whatever we’re doing right now isn’t working.
The Drug Approval Process
The resources required for a drug to be fully developed and approved and enormous. It can take years and millions of dollars to get a single drug to market. Of the drugs that enter development, only a small percentage make it to human trials, let alone make it to market. There’s a very good reason for this: human chemistry is delicate and pharmaceuticals can cause serious damage, even when they’re controlled.
The FDA exists in America to ensure consumers aren’t exposed to dangerous substances that are marketed as safe to consume. This covers both food and drugs, with serious attention paid to drugs. All pharmaceuticals go through the FDA approval process, whether they’re name-brand or generic, for wide use or orphan drugs.
The Dangers of More Approvals
Recently, the FDA has been expediting large numbers of drug approvals, largely for generics and Breakthrough Designation (BTD) drugs. This can be seen as a net positive, as increased generic approvals could mean that patients get necessary medications faster and cheaper, and approval for BTDs could provide much-needed relief for those with rare or life-altering illnesses. Unfortunately, this isn’t always the case.
Of the many generic drug approvals by the FDA between 2018 and through June 2019, less than two-thirds are not widely available. During that time, brand name manufacturers raised prices by 5%. This is mainly due to legal issues, since brand names hold the patents to their drugs for a set period of time, ensuring exclusivity. This is not necessarily a flaw in the system since that period of exclusivity is what pays for research and development of other medications. The problem arises when expedited approvals lead to missing key risks of a medication.
BTD drugs are arguably more dangerous, as they can be rapidly approved in a significantly shorter time frame than non-BTD medications. This increases the chances of major risks to be overlooked.
Innovation should always be encouraged, and the FDA should do what it can to keep the public safe and healthy, but when goals for faster approvals interfere with due process, people’s lives get risked.