“The objective is to win: fairly, squarely, decently, win by the rules, but still win.” – Vince Lombardi
When it comes to prescription medicines, patients win when companies innovate new cures and treatments. Patients also win when more affordable generic versions of those medicines enter the market. Unfortunately, some brand manufacturers aren’t playing by the rules.
If this were a football game, the penalty would be called “delay of game.” These manufacturers take advantage of loopholes in Food and Drug Administration (FDA) safety programs to artificially extend their monopolies and keep generic or biosimilar versions of their product from coming to market.
This behavior leads to an unlevel playing field where patients are left holding the bill, and it’s costing the U.S. healthcare system billions of dollars a year.
This shouldn’t be a zero-sum game. Brand-name manufacturers should not be permitted to flout the rules established by Congress to protect patients from risky medicines and use them to prevent generics from taking the field.
If we all play by the rules, everybody wins.
Generic and biosimilar drug makers must purchase samples of branded prescription medicines to make sure they understand how the medicine is made and reacts in the human body. This is a mandatory part of the FDA approval process to show that the generic or biosimilar medicine meets the same rigid standards as the corresponding brand-name product. The FDA requires some products to have special safety restrictions if they have a higher risk of causing serious side effects or if they might be used illicitly. AAM supports these restrictions because they protect patients from harm while ensuring access to needed therapies.
Here’s the problem. Some brand manufacturers are gaming the system and hiding behind these requirements. As a means of preventing more affordable versions of their medicines from being developed by competitors. The tactic has proven so effective that an increasing number of brand-name companies have voluntarily put into place artificial restrictions to limit who can purchase their product, even though the FDA has not required any such restrictions.
No matter which approach they take, the brand industry uses these tactics to run up the score on patients and charge them inflated prices.
Fortunately, the FDA has recognized these abuses, noting that they disadvantage patients in the form of higher prescription drug costs. Bipartisan leaders in Congress have introduced legislation that would close the loopholes and ensure patients benefit from the timely entry of more affordable versions of these high-cost branded medicines. You can help: Contact your Representative and Senator and ask them to co-sponsor the CREATES Act (S. 974/H.R. 2212), a bill that ends abuses of FDA safety programs and ensures patients win when more affordable treatments become available.
By Michael Brzica, AAM Vice President of Federal Government Affairs