There are few issues where agreement is louder than when you ask Americans whether Congress ought to do more to lower the cost of prescription drugs. More than 160 million Americans receive healthcare benefits through work, and large employers pay more than 80 percent of the healthcare costs for their employees.
These large plan sponsors are struggling to deliver quality, affordable health benefits to workers, partly due to the ever-increasing cost of prescription drugs. Relief is needed, and it is now required.
Robust competition from generic drugs and biosimilars is essential to making prescription drugs more affordable. Many of the problems in the prescription drug market are a result of failure by parties to abide by the standards established by Congress in 1984, usually referred to as the Hatch-Waxman Act.
The law strives to reward innovators by granting limited patent exclusivity to recover their research-and-development costs before facing competition from generic and biosimilar products. However, myriad strategies are regularly used by drug companies to delay or entirely escape competition, leaving prices high for patients and employers.
Attempts to enact common-sense, reasonable regulatory reforms have been met with continued resistance and significant spending by those who have a financial stake in the status quo. The “interchangeability” designation for biosimilars is a perfect example of special interests attempting to thwart competition. Under the guise of “patient safety” and “preserving the doctor/patient relationship,” a lobbying effort was quietly executed to pass state laws restricting substitution before the first set of biosimilars were widely available.
By 2019, two-thirds of states had passed legislation that deemed substitution should occur only when the Food and Drug Administration has designated a biologic product “interchangeable,” and that the prescribing physician should be able to prevent substitution.
These actions were accompanied by a misinformation campaign to “educate” physicians that biosimilars have similar, but not the same, efficacy and safety profiles. The misinformation was so egregious that the FDA stood up a website dedicated to correcting this misinformation for patients, pharmacists and physicians. Sadly, the damage was done. Despite evidence proving there is no clinically meaningful difference between biosimilars and their reference biological drugs, confusion and stigma around interchangeability remain.
Congress needs to act. The Senate has taken a significant step with Sen. Mike Lee, R-Utah, and Ben Ray Luján, D-New Mexico, introducing the Biosimilar Red Tape Elimination Act. The bipartisan bill updates outdated FDA rules by eliminating switching studies that delay interchangeability — studies that serve no purpose other than delaying Americans’ access to lower-cost biosimilar alternatives. The legislation removes barriers to biosimilar availability and reflects efforts that the FDA has tried to achieve, but it requires help from Congress.
FDA Commissioner Marty Makary expressed his support for these changes in recent congressional appearances.
With strong Senate support for these reforms, industry is on the attack, setting its sights on the House and working furiously to weaken the Lee-Luján legislation. Opponents want to weaken the bill by adding extra clinical studies for interchangeability as a requirement for biosimilar approval. If successful, the bill will no longer benefit patients by speeding access to cheaper drugs but instead will cost patients by adding another layer of time-consuming studies before a biosimilar would be available.
As consumers struggle with the cost of everything from eggs to energy, Congress has a defining choice. Does the House join the Senate, stand up to industry, and end these anti-competitive, non-scientific and nonsensical obstacles to bringing cheaper alternatives to market quicker? Or will they choose to leave practices unchanged, making it harder to develop more affordable biosimilars?
Many believe that if action to curb high prices is not taken soon, it will create more momentum for policies like government price setting, or worse, allow single-payer healthcare to prevail eventually, as there would be no other way to pay skyrocketing U.S. healthcare costs.
Increasing the affordability of prescription drugs is not a Republican or Democratic issue — it is a patient issue. Millions of Americans are looking to Congress to provide relief from high and rising prescription drug costs that are threatening the health and financial well-being of our nation’s families, large employers, small businesses and communities. The time to act is no to take action in the House to introduce and pass the Lee-Luján bill.
