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Medication Equity and Drugs Savings Act II (MEDS II)

The first bill I introduced as a U.S. Senator was the Medicine Equity and Drug Safety Act (S.215) that would allow individuals and wholesalers to reimport medications from other countries in order to sell them in the U.S. at lower prices. Prescription drug prices in Canada are much lower than they are here. By allowing reimportation, it will encourage real competition in the drug industry and lower the prices of drugs in the United States.

I have also cosponsored the Prescription Drug Price Parity for Americans Act (S.2244) that will allow individuals, wholesalers and U.S.-licensed pharmacists to reimport prescription drugs from Canada.

This legislation would amend the Federal Food, Drug and Cosmetics Act to allow American consumers to benefit from international price competition for prescription medicine in two ways:

1. The bill would give individuals a waiver to import prescription drugs from Canada for their own personal use, in a 90-day supply as long as they have a prescription. This provision is intended to give American consumers confidence that, if they follow the rules for personal importation, they won't have to worry that their medicines will be stopped at the border.



2. The bill allows U.S.-licensed pharmacists and drug wholesalers to import FDA-approved medications from Canada only. The many safety requirements included in the Medicine Equity and Drug Safety Act (P.L. 106-387), which was passed by the Senate in 2000 by a 74-21 vote, would be left in place.

While keeping in place the safety requirements of the MEDS Act of 2000, the bill would make some improvements to the law:

• The bill would limit commercial importation by pharmacists and wholesalers to FDA-approved drugs coming only from Canada. According to the CRS, Canada has a drug approval and distribution system comparable to that of the U.S. FDA Senior Associate Commissioner William Hubbard testified at a Senate Commerce Committee hearing that he would have a relatively high degree of confidence in drugs imported from Canada.



• The bill would become effective immediately. The Secretary would have the ability to immediately suspend the importation of any covered product should it be counterfeit or otherwise violate any of the requirements of the MEDS Act.



• The bill eliminates the 5-year sunset in the MEDS Act. Of course, Congress is always free to amend the law or even repeal it, if warranted in the future.



• Includes a non-discrimination provision intended to ensure that drug manufacturers cannot get around the law by manipulating the supply of prescription drugs they make available to pharmacists and wholesalers.



• Provides that the manufacturer of a covered product provide written authorization for the importer to use the approved labeling for that product.



• Requires Canadian pharmacies and wholesalers that provide prescription drugs for importation into the United States to register with HHS. According to CRS, Canadian pharmacies and wholesalers are licensed and inspected by the Canadian federal or provincial governments.



• Excludes from importation drugs that are infused, intravenously injected, and inhaled during a surgical procedure, and all controlled substances. (The MEDS Act already prohibits the importation of biological products and most controlled substances.)
  

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