Q. What can be done to drive down prescription drug costs for U.S. consumers?
A. There are two specific barriers to lower prescription drug costs that Congress should tear down immediately. One is agreements that delay market entry of generic drugs. The other is the prohibition on importing prescription drugs into the United States.
Generic drugs save consumers an estimated $8 to $10 billion a year. Unfortunately for consumers, brand-name drug companies and generic drug manufacturers have been entering into agreements not to produce generic versions of their drugs for a certain period of time. According to Federal Trade Commission economists, these pay-for-delay schemes stall market entry of generic drugs by an average of 17 months, keeping costs unnecessarily high for all consumers and also diminishing the sustainability of federal health care programs, such as Medicare and Medicaid. Until 2003, these deals could even be worked out in secret. That was before the Drug Competition Act became law. I cosponsored this legislation and included it in the Medicare Modernization Act, which I authored in the Senate (this was the law that created the Medicare prescription drug benefit). The Drug Competition Act requires drug companies to report all proposed deals with potential generic competitors to the Federal Trade Commission and the Department of Justice.
Since 2006, I have been working with Senator Herb Kohl of Wisconsin to advance legislation that would further address the problem of pay-for-delay deals in the pharmaceutical industry. Our Preserve Access to Affordable Generics Act would make it illegal for generic drug manufacturers to agree to limit or forego research, development, manufacturing, marketing, or sale of a drug product for any period of time. We’ve won Judiciary Committee approval for our legislation, but it has yet to be brought up in the full Senate. Passage of our bipartisan bill would bring generic drugs to the market faster, increase drug competition, and drive down prices for consumers. Senator Kohl and I plan to introduce the legislation again in the upcoming Congress.
A second major issue is that under current law, it remains illegal for anyone to import a prescription drug other than the manufacturer of the drug. A prescription drug can cost much more in the U.S. than the exact same drug costs in another country, meaning Americans pay more than their fair share of the high cost of research and development. Giving American consumers access to imported prescription drugs would force pharmaceutical companies to re-evaluate this unfair pricing strategy and drive U.S. prices down. It’s a free-trade issue. American consumers are able to buy almost every other product available from other countries. The same should be true for prescription drugs.
I have been fighting to broaden the legal authority to import prescription drugs since 2000. In 2004, I introduced comprehensive legislation, and in 2005, I combined that measure with a proposal sponsored by Senators Byron Dorgan of North Dakota and Olympia Snowe of Maine. In 2007 and 2009, I introduced the Pharmaceutical Market Access and Drug Safety Act – which would legalize the importation of prescription drugs offered for sale in certain foreign markets – with Senators Dorgan and Snowe, and Senator John McCain of Arizona.
Q. How can we be sure that a prescription drug purchased from another country is safe?
A. The legislation I've sponsored and supported applies only to drugs approved by the U.S. Food and Drug Administration that were produced in plants located in countries with comparable safety standards and approved by the Food and Drug Administration. The Food and Drug Administration would inspect approved facilities frequently, and it would have the ability to trace a drug’s pedigree all the way back to the manufacturer. In 2008 and 2009, I also introduced the bipartisan Drug and Device Accountability Act with Senator Ted Kennedy of Massachusetts to enhance the Food and Drug Administration’s oversight of domestic and foreign drug manufacturing. This legislation would expand the agency’s registration and inspection of production facilities here and overseas, and enhance its ability to respond when drugs are found to be unsafe.