These days, it seems like it would be difficult to get the majority of Americans to agree on anything. Everywhere you look, it seems the country is divided on almost every issue, but there is one issue that unites us: lowering the cost of prescription drugs.
Beyond partisan and ideological lines, Americans agree that the cost of life-saving drugs is out of control. Given the number of Americans who rely on these drugs and their skyrocketing costs, this sentiment is understandable.
According to a poll released by the Kaiser Family Foundation last month, 62% of all Americans say they take at least one prescription drug, while 83% say the cost of prescription drugs is unreasonable. Unsurprisingly, Americans think this way, given that the cost of brand-name prescription drugs has more than tripled in the past 10 years, according to the AARP Public Policy Institute.
Branded pharmaceutical companies will argue that these price increases are justified to cover the huge R&D costs associated with new drugs and treatments. The problem with this argument is that it ignores the amount of taxpayer-funded research through the National Institutes of Health that contributes to the development of these drugs and treatments. It also ignores the fact that even older, unpatented and outdated drugs are experiencing dramatic price increases, due to a lack of competition.
The cause of this prescription drug crisis is clear. Branded pharmaceutical companies are putting profits ahead of public health and patients are paying the price. It is time for Congress to step in and limit the ability of these companies to get rich off the shoulders of patients.
One way to do this is to make it easier for generics and biosimilars to enter the market. These drugs are as safe and effective as brand-name prescription drugs, but they cost less. According to the Association for Accessible Medicines, the average brand co-payment is $ 55.82, while the average generic co-payment comes in at $ 6.61. In fact, 93 percent of generic prescriptions are filled for $ 20 or less. Unsurprisingly, branded pharmaceutical companies do everything they can to prevent generics and biosimilars from reaching the market.
Drug manufacturers can hold patents on the new drugs they create for 20 years, as compensation for the cost of research and development that goes into these treatments. This gives drug manufacturers the exclusive rights to sell a drug over that 20-year period. The problem is that drug companies regularly tweak the drug formula to extend the patent beyond the initial two decades, creating so-called “patent thickets.” This practice gives them a longer monopoly and blocks out-of-market competition.
Another problem facing generics and biosimilar manufacturers is that a key funding mechanism to accelerate the approval of safe and effective drugs will expire on 1 October. Fees collected through the Amendments to Generic Drug Consumer Rates (GDUFA) cover 70% of the FDA program that ensures safe approval of generic drugs, while fees collected through the Biosimilar User Fee Act (BsUFA) cover 60%. % of the program for the approval of biosimilars.
The good news for consumers is that the House has passed its version of the Food and Drug Amendment Act. The Senate should quickly follow suit.
Increasing the number of generics and biosimilars on the market is a key way to reduce the cost of prescription drugs for patients, and it’s incredibly popular too. The Kaiser Family Foundation survey cited above also found that an overwhelming 88% of Americans support policies that make generic drugs easier to market.
Funding provided by GDUFA and BsUFA strengthen the FDA’s ability to more quickly approve generics and biosimilars and bring them to market. It also provides the FDA with resources to improve the frequency and quality of drug inspections. The House version of these bills contains much-needed language that would add more surprise inspections and require more internal coordination by the FDA to prevent quality problems from causing drug shortages. Quickly switching to these bills will provide patients with an added layer of protection and confidence in both the safety and availability of life-saving medicines.
It is rare for Congress to have the opportunity to lower drug prices for consumers and improve public health by advancing a hugely popular policy that has broad bipartisan support. The re-authorization of these rights-of-use agreements is not the only step Congress must take to curb the soaring prices of prescription drugs, but it is a necessary and achievable step that should take place in a timely manner.
Ken McEldowney is executive director of Consumer Action, a national consumer advocacy and education organization based in San Francisco.