Fact Sheet

Policy Options to Manage Drug Spending

Pew examines various proposals aimed at reducing costs and ensuring patient access to needed therapies

Prescription drug costs in the United States are increasing, with net spending on pharmaceuticals expected to exceed nearly $400 billion by 2020. With patients and taxpayers increasingly shouldering this financial burden, lawmakers have introduced a wide range of policies to address rising pharmaceutical costs. 

Pew is creating a series of fact sheets summarizing many of these proposed policies, touching on topics such as competition, transparency, and Medicare Part B and D reforms. They will also evaluate the potential each policy has to manage drug spending and outline key issues for policymakers to consider.

Policy Options Fact Sheet Series

Policy Proposal: Importation of Prescription Drugs

Allowing prescription drugs to be purchased and imported from abroad has the potential to lower health care costs in the U.S. In the short term, patients could access some medicines at lower prices, since brand pharmaceuticals are generally more expensive in the United States than in other high-income countries, in part because some nations have taken steps to limit drug prices.

Policy Proposal: Improving Generic and Biosimilar Developer Access to Brand Pharmaceutical Samples

Generic and biosimilar manufacturers, or drug developers, report that they have been unable to purchase samples of innovator drugs for their product development. Without access to these drugs, generic developers cannot conduct the testing required for Food and Drug Administration approval. They can sue brand companies for violating antitrust law, but this type of litigation can take years to conclude, and it can be difficult for generic developers to demonstrate that a brand developer’s actions caused harm to either them or consumers. As a result, patient access to generic drugs is delayed.

Policy Proposal: Banning or Limiting Reverse Payment Agreements

Reverse payment agreements, also known as “pay-for-delay” deals, are settlements that involve a brand pharmaceutical manufacturer paying one or more potential generic competitors to resolve patent infringement lawsuits and agree upon a date by which the generic product can come to market. In fiscal year 2014 there were 21 such settlements involving 20 different branded drugs.

Policy Proposal: Expedited Review of Generic Drug Applications

Competition from generic drugs can significantly reduce spending on pharmaceuticals. The number of competitors in a market can also affect drug prices. A Food and Drug Administration analysis of national sales data found that the first generic version of a drug is typically priced only slightly lower than the brand product but that the availability of a second generic version is associated with an average price of about half that of the brand drug.

Policy Proposal: Reducing the Exclusivity Period for Biological Products

Biological products, or biologics, are drugs made up of proteins or other materials derived from living cells through a complex manufacturing process. They are used to treat a wide range of health conditions, including cancer, rheumatoid arthritis, and multiple sclerosis, and are some of the most expensive drugs on the market, measured by both unit price and net contribution to spending. In 2015, eight of the 10 highest-expenditure drugs in Medicare Part B were biological products, and growth in the spending on biologics has exceeded 10 percent for each of the past five years.

Media Contact

Megan Meline

Manager, Communications

202.552.2275