Issue in Focus
One of the most urgent problems facing our health care system today, and one of the primary causes of rising health insurance premiums in the United States, is the skyrocketing cost of prescription drugs. One in four patients say that they have refrained from filling a prescription because it was too expensive, and nearly three-quarters of Americans believe prescription drug costs are unreasonably high.
There are many problems contributing to the unrelenting cost inflation of prescription drugs – including the FDA’s outdated, byzantine approval process for new drugs, which can last as long as 13 years – but one of the most egregious, and easy to fix, is the ability of brand-name drug companies to unfairly block generic drug companies from entering the market with more affordable products.
This is largely a problem of the government’s own making. The FDA is allowed to require drug manufacturers to submit to what’s called a Risk Evaluation and Mitigation Strategy, which may include restricted distribution. This scenario makes the brand the sole gatekeeper for a generic competitor attempting to enter the market – even after patent expiration – and brands sometimes use this situation to refuse to sell samples to generics. This prevents generics from conducting the laboratory tests that are required to gain FDA approval. Or the brand name firms will block generics from participating in their FDA-mandated safety protocol, which is a prerequisite for government approval.
Restricting generic drug manufacturers from accessing samples of new drugs allows brand name companies to dramatically inflate the prices of their drugs. For instance, in 2015 Turing Pharmaceutical increased the price of its anti-parasitic drug Daraprim 5000 percent overnight, from $13.50 to $750 per pill.
To combat outrageous, abusive practices like this, I recently teamed up with a bipartisan group of senators to introduce the Creating and Restoring Access to Equivalent Samples (CREATES) Act of 2016. The CREATES Act provides an efficient pathway for generic drug manufacturers facing one of these delay tactics to bring an action in federal court seeking injunctive relief, in order to obtain the sample necessary for bioequivalent testing or enter court-supervised negotiations for a shared safety protocol.
If we’re ever going to bring the cost of health-insurance premiums and prescription drugs under control we must reform the Food and Drug Administration’s excessively onerous, time-consuming regulatory process. The CREATES Act is an essential first step in that process. It is a commonsense, bipartisan measure that will provide real, immediate relief to a serious problem.