October 4, 2022
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Must-pass health bills give Congress (another) chance to lower drug costs

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These days, it seems like it would be hard to get the majority of Americans to agree about anything. Everywhere you look, it feels like the country is divided on nearly every subject, but there is one issue that unites us: lowering the cost of prescription drugs.

Across partisan and ideological lines, Americans agree the cost of life-saving medications 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 survey released by the Kaiser Family Foundation last month, 62 percent of all Americans report currently taking at least one prescription medication, while 83 percent say the cost of prescription drugs is unreasonable. It is not surprising that Americans feel this way, given that the cost of brand name prescription drugs has more than tripled in the last 10 years, according to the AARP Public Policy Institute.

Brand drug companies will argue that these price increases are justified to cover the enormous research and development costs that go into new drugs and treatments. The problem with that argument is 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 older, off-patent drugs that have not been updated are also seeing dramatic price increases, because of lack of competition.

The cause of this prescription drug crisis is clear. Brand name 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 on the backs of patients.

One way to do this is to make it easier for generic drugs and biosimilars to enter the market. These drugs are just as safe and effective as brand name prescription drugs, but they cost less money. According to the Association for Accessible Medicines, the average brand-name co-pay is $55.82, while the average generic co-pay comes in at $6.61. In fact, 93 percent of generic prescriptions are filled for $20 or less. Not surprisingly, brand pharmaceutical companies do everything they can to prevent generics and biosimilars from reaching the market.

Drugmakers are allowed to 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 exclusive rights to sell a medication over that 20-year period. The problem is that drug companies routinely tweak the formula of the drug in order to extend the patent beyond the initial two decades, creating so-called “patent thickets.” This practice gives them a longer monopoly and locks competition out of the marketplace.

Another issue facing generic and biosimilar manufacturers is that a key funding mechanism to expedite approval of safe and effective drugs is set to expire on Oct. 1. The fees collected through Generic Drug User Fee Amendments (GDUFA) cover 70 percent of the FDA program that ensures safe approval of generic drugs, while the fees collected through the Biosimilar User Fee Act (BsUFA) cover 60 percent of the program for biosimilar approval.

The good news for consumers is that the House passed its version of the Food and Drug Amendment Act. The Senate should quickly follow suit.

Increasing the number of generics and biosimilars that hit the market is a key way to reduce the cost of prescription drugs for patients, and it also happens to be incredibly popular. The Kaiser Family Foundation survey cited above also found that an overwhelming 88 percent of Americans support policies that make it easier to bring generic drugs to market.

The funding provided by GDUFA and BsUFA bolster FDA’s ability to more quickly approve generics and biosimilars and get them to market. It also gives FDA the 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 greater internal FDA coordination to prevent quality issues from causing drug shortages. Moving quickly on 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 that Congress has an opportunity to lower drug prices for consumers and improve public health by advancing an overwhelmingly popular policy that has broad bipartisan support. Reauthorizing these user fee agreements is not the only step Congress needs to take to rein in skyrocketing prescription drug prices, but it is a necessary and achievable step that should happen in a timely fashion.

Ken McEldowney is executive director of Consumer Action, a San Francisco-based national consumer advocacy and education membership organization.



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