THEY SAID IT! LAWMAKERS AND HEALTH CARE EXPERTS CALL FOR BIPARTISAN SOLUTIONS TO BOOST GENERIC AND BIOSIMILAR COMPETITION TO LOWER PRESCRIPTION DRUG PRICES

HELP Committee Hearing Puts the Spotlight on Big Pharma’s Anti-Competitive Tactics That Block More Affordable Alternatives and Keep Drug Prices High

In case you missed it, the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing Thursday titled “Making Medicines More Affordable: How Competition Can Lower Drug Prices.”

Lawmakers from both parties and expert witnesses highlighted how Big Pharma’s egregious playbook of price hikes exceeding inflation, skyrocketing launch prices on new medications and anti-competitive tactics – like patent thicketing – are driving health care inflation in the United States.

During the hearing, Senators and health care experts emphasized that boosting competition from generics and biosimilars is one of the most effective, market‑based tools available to lower drug prices and crack down on Big Pharma’s abuse of the system to extend monopoly pricing power. Lawmakers and experts called for action on bipartisan solutions like the Biosimilar Red Tape Elimination Act (S.1954), Ensuring Timely Access to Generics Act (S.3014), Skinny Labels, Big Savings Act (S.43), Fair Accountability and Innovative Research (FAIR) Drug Pricing Act and additional market-based policies to eliminate barriers to greater competition to effectively lower drug prices for American consumers.

Here what lawmakers and the experts had to say:

U.S. Senator Bill Cassidy (R-LA), Chairman, Senate Committee on Health, Education, Labor & Pensions: “So let’s start with what works – generics. About 90 percent of all drugs dispensed in the U.S. are generics, and they are affordable. In 2024, generics generated roughly $450 billion in savings. No other country has a generic system that works as well as ours… While biologics only account for about five percent of all prescription drugs in the U.S., that five percent makes up almost half of all prescription drug spending, and that is what is driving cost… This committee has taken steps to make both generics and biosimilars less expensive. The Ensuring Timely Access to Generics Act and the Biosimilar Red Tape Elimination Act are great bills I am working to make into law, and we need a free-market approach.”

U.S. Senator Bernie Sanders (I-VT), Ranking Member, Senate Committee on Health, Education, Labor & Pensions: “In 2024, these 16 drug companies made $107 billion in profit. Last year, these same companies made $177 billion in profits. Just a few examples… Bristol-Myers Squibb raised the price of its cancer drug Opdivo by more than $10,000. Merck raised the price of its cancer drug, Keytruda, by more than $12,000.”

U.S. Senator John Hickenlooper (D-CO): “One of the impediments to greater competition that you were discussing, is the impact of excessive litigation for brand manufacturers to stifle the generic competitors who would otherwise be bringing these lower cost products to market. I couldn’t agree more. We have a bill – Senator Collins, Senator Welch, Senator Cotton and I – called Skinny Labels, Big Savings Act, that’s going to help address this issue. The Skinny Labels, Big Savings Act is going to help make sure that the long-standing provisions in Hatch-Waxman are not undermined by the enormous costs of these mountains of litigation. It’s going to allow more generic manufacturers to not only develop the competitor drugs but ensure that those medications get to the marketplace in a circumstance, where they can take that price advantage and save people money.”

U.S. Senator Tammy Baldwin (D-WI): “They [patients] are also struggling to pay for their prescription drugs while pharmaceutical manufacturers continue to raise prices and rake in enormous profits. Americans pay the highest prices for prescription drugs in the world, and this is unacceptable… My FAIR Drug Pricing Act, which passed this committee with bipartisan support last Congress, would bring basic transparency to the prescription drug market by requiring manufacturers to justify the exorbitant prices they charge working families. For the first time, the public would have advance notice of proposed price increases and more granular information about how these drug prices are determined… I look forward to working with my colleagues to increase transparency and welcome any of my Republican colleagues to join me in working again on the FAIR Drug Pricing Act moving forward.”

Dr. Brian Miller, Associate Professor of Medicine, The Johns Hopkins University School of Medicine: “There are a bunch of proposed bills in front of the committee: the Biosimilar Red Tape Act, the Expedited Access to Biosimilars Act. These are a step in the right direction… We also know that generics save untold billions every year… We also need to incentivize market entry in generic markets where there isn’t much competition, where there’s no competition.”

Lawmakers and witnesses applauded recent moves made at the U.S. Food and Drug Administration (FDA) – recommending more efficient testing standards designed to promote and expedite biosimilar drug development – that could reduce barriers to fostering greater competition from more affordable alternatives to high-priced biologic drugs.

U.S. Senator Bill Cassidy (R-LA), Chairman, Senate Committee on Health, Education, Labor & Pensions: “The FDA has taken recent steps to streamline regulatory requirements and to incentivize biosimilar drug development. Their changes to guidelines are estimated to reduce the cost of certain studies by up to 50 percent, which decreases the cost for the developer and therefore for the patient.”

Dr. Brian Miller, Associate Professor of Medicine, The Johns Hopkins University School of Medicine: “We need more biologic drug price competition. I’m on the board of the North Carolina State Health Plan. We cover 750,000 state employees, dependents and retirees. Last year, we spent $293 million on biologics. It was 32 percent of our net pharmacy spend, and that was a nine percent increase from the prior year. So, I think around three times the rate of consumer price inflation. If we look at what’s happening in FDA product regulation, FDA Commissioner Makary has done a great job to begin the process of streamlining unnecessary pre-market requirements such as comparative clinical efficacy studies.”

Ryan Long, Director of Congressional Relations and Senior Research Fellow, Paragon Health Institute; Nonresident Senior Scholar, USC Schaeffer Institute: “I want to commend the FDA for its work in further streamlining biosimilar approvals, as Dr. Miller mentioned. In 2024, FDA proposed that switching studies are no longer necessary for an interchangeability designation. In 2025, the FDA eliminated comparative clinical efficacy study requirements. The FDA said that this should shave three to four years off the approval process. These are reforms that Congress should consider codifying. With the success of getting more generics and biosimilars to the market, we’re seeing more competition, more options, and more savings. Even though 90 percent of all prescriptions in America are generics, they represent only 12 percent of total drug spending. U.S. generic prices are now 33 percent below the OECD median. The expanding biosimilar market is also bringing savings. According to a 2024 report, savings from biosimilar use increased to $12.4 billion in 2023 alone. Together, generics and biosimilars have saved the U.S. healthcare system more than $3 trillion in the last decade. According to an HHS analysis of 2023 Medicare claims data, for the eight biologics subjects to biosimilar competition in Medicare Part B, spending on those specific drugs was approximately 62 percent lower than it would have been absent the biosimilar.”

Senator Susan Collins (R-ME) highlighted concerns about how the FDA’s citizen petition process – designed to allow public input on drug safety and efficacy – has been exploited by the pharmaceutical industry to delay the approval of generic and biosimilar medicines and undermine competition.

U.S. Senator Susan Collins (R-ME): “I want to ask you about another reform that Senator Shaheen and I have been pushing, and it would reform the FDA’s citizen petition process. Now that sounds great, who would be against citizen petitions, but in fact, they’ve often been used to delay the approval of generic drugs or biosimilars. Could you talk about this anti-competitive process that has a good intention, but can be misused?”

Dr. Brian Miller, Associate Professor of Medicine, The Johns Hopkins University School of Medicine: “Absolutely. The citizens’ petition process allows anyone to basically functionally write a letter to the FDA asking for a review or express a safety or efficacy concern. Sometimes, some manufacturers use that as a way to delay entry and sort of gum up the works. There was an [Federal Trade Commission] FTC case where a company filed, I think it was 43 citizen petitions to delay entry. That’s blatantly anti-competitive. The FDA should have the authority to dismiss those, and then we should also have a referral channel to the competition authorities, the Federal Trade Commission and the Department of Justice, and the FDA should regularly refer bad actors to our competition authorities for oversight and enforcement. And in fact, we could actually require the FDA and FTC to file an annual report about anti-competitive abuses of the FDA regulatory process – 100 percent agree with you.”

Senator Maggie Hassan (D-NH) outlined GlaxoSmithKline’s egregious Flovent scheme, designed specifically to keep prices high on the widely used asthma inhaler, triggering coverage disruptions and worse outcomes for patients.

U.S. Senator Maggie Hassan (D-NH): “We’ve talked a little bit about the abuse of citizen petitions, but Big Pharma has other techniques as well. It blocks lower cost generic drugs from entering the market by using frivolous patents and exploiting other loopholes to extend the patent protections for their medications for years or decades beyond the exclusivity period provided under the law. When companies engage in years of patent games and litigation, patients are forced to pay for higher brand name drugs… Two years ago, the drug company GlaxoSmithKline, GSK, pulled Flovent, which was one of the most common inhalers for children, off the market. This action caused significant harm to young children with asthma, many of whom were forced to go without an inhaler. It’s a very specific thing. All young children can’t use all inhalers for a bunch of reasons. GSK then replaced its inhaler with an identical drug, which it distributed through a partner company. Making more money, by the way, than they did with the original patented Flovent. This so-called authorized generic allowed GSK to continue to profit without having to pay the hundreds of millions in rebates that it owed to the Medicaid program for raising its prices faster than inflation. After I launched an investigation into GSK’s actions, the FDA approved the first ever true generic of Flovent last month, and families will soon have a lower-cost inhaler option for their kids.”

Watch the full U.S Senate Committee on Health, Education, Labor & Pensions (HELP) hearing HERE.

Read more about how biosimilar competition lowers out-of-pocket costs for patients HERE.

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.