Excessively high drug prices threaten the financial security, health and well-being of patients and their families every day. They also financially strain federal and state health budgets and the taxpayers who fund them, as well as the many employers who seek to offer affordable health insurance to their employees. We simply cannot continue to pay for unjustifiably high-priced drugs that increase the bottom lines of Big Pharma at the expense of patients and taxpayers. Bipartisan, market-based solutions below will help restore a functioning drug market for Americans.

Competition

Big Pharma’s abuse of the system to block competition from less expensive generics and biosimilars cost consumers more than $40 billion in just one year. These costs will only continue to grow absent intervention.

Address patent “thicketing”

Drug makers construct patent thickets by obtaining dozens or even hundreds of patents for their branded products after FDA approval to prevent and delay market entry from less costly generics and biosimilars. Patent “thickets” on just five brand drugs cost consumers more than $16 billion in a single year. A range of reforms and various bipartisan legislation would give the U.S. Patent and Trademark Office (USPTO) and the FDA all of the authorities and resources needed to stop these abuses.

Promote biosimilar use

The 12-year market exclusivity period for brand biologics should be reduced to seven years. Congress should enact the Biosimilar Red Tape Elimination Act to increase biosimilar substitution. Medicare and Medicaid should continue and expand upon administrative policies that foster and promote biosimilar uptake.

Curb anti-competitive behavior

Actions should be taken to stop Big Pharma’s various schemes to maintain brand monopolies and prevent competition from lower cost generics and biosimilars, including “product hopping,” “evergreening,” abuses of the FDA “citizen petition” process, abuses of the Orphan Drug Act and entering into anti-competitive patent settlements.

Drugs must be more affordable so that patients never are presented with the choice of taking the medications they need to get well and paying for other necessities like food and housing. 

Scrutinize lockstep “shadow pricing”

Drug makers have used lockstep “shadow pricing” to maintain price “parity” and use their competitors’ price increases as justification for their own price increases. Scrutiny should be applied to therapeutic drug markets with the greatest potential for this anti-competitive behavior. Some of the drug companies making the new weight loss drugs, for example, are the very same companies that make insulin – a therapeutic drug class where separate investigations by the Senate Finance Committee and House Oversight and Investigations Committee found that ”shadow pricing” significantly raised prices over many years costing diabetes patients and taxpayers billions of dollars.

Rein-in costs especially for weight loss drugs and cell and gene therapies

Makers of the new weight loss drugs are charging U.S. patients as much as 5.5 times more than patients abroad for the same medications and, while Medicare currently doesn’t cover these drugs, estimates indicate costs to Medicare could be $13.6 billion to $26.8 billion in just a single year. The Congressional Budget Office (CBO) predicted that covering GLP-1 weight loss drugs “at their current prices, would cost the federal government more than it would save from reducing other health care spending.” Newly-approved cell and gene therapies have sky-high prices in the millions of dollars that can break state Medicaid budgets and are projected to cost taxpayers an estimated $300 billion over 15 years. Drug makers must have financial skin in the game for the high-priced therapies and lower costs for patients and payers.

Ensure launch prices are justified

Drug makers should be required to conduct comparative effectiveness studies comparing their new drugs to existing drugs on the market. HHS should issue an annual report on launch prices and launch price trends to systematically monitor their impacts on consumers and taxpayers. The Patient-Centered Outcomes Research Institute (PCORI) and Agency for Healthcare Research and Quality (AHRQ) should be empowered with the resources and authorities necessary to conduct cost-effectiveness work to assess whether launch prices and ongoing price increases, align with actual value to patients.

Lower Medicare drug costs

Medicare should maximize use of drug value assessments from non-partisan, independent organizations like ICER into the drug price negotiation process – so long as those value assessments reflect the rights and needs of all patients and do not discriminate against the disabled, elderly, or terminally ill. Medicare also should be as transparent as possible about its justification for negotiated prices, so that the public knows negotiated prices represent the lowest possible prices that Medicare can obtain. The rebate rule should be permanently rescinded and Part D plans should have more flexibility to manage high-cost drugs.

Transparency

Drug manufacturers routinely justify their pricing decisions by citing industry-funded research, which claims that it costs $2.6 billion in R&D to bring a new drug to market. However, a JAMA study found that drug prices do not correlate with R&D costs, making pricing transparency critical.

Enhance pricing transparency and reporting

The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act should be enacted to enhance drug pricing transparency.

Require list prices in direct-to-consumer (DTC) advertising

Drug makers spent an astounding $8.1 billion on DTC advertising pushing brand drugs in 2022. Congress should enact the Drug-Price Transparency for Consumers Act to require drug makers to disclose list prices in DTC ads.

Disclose taxpayer investments in drug research

Data show that funding from the National Institutes of Health contributed to virtually all of the drugs approved by the FDA between 2010 – 2019. Drug makers should be required to disclose R&D costs for drugs, including the amount funded by taxpayers.

Thwart patient assistance schemes that increase costs

Third-party patient assistance programs can help patients afford high-priced drugs – but in many cases drug makers use them to shield patients from high prices while their health care premiums continue to grow. Drug maker patient assistance should be prohibited in commercial plans, and co-pay accumulator programs that discourage inappropriate drug company assistance should be explicitly permitted in federal health programs and commercial health plans.