	Introduction

In recent years, as prices of prescription drugs have risen, many in Congress have sponsoredlegislation to permit the importation of Food and Drug Administration (FDA) approved drugs fromless expensive foreign sources. In the 109th Congress, three pairs of bills have been introduced torepeal the existing import restrictions and provide for limited forms of importation of prescriptiondrugs. Current law and the bills all seek to balance the availability of imported prescription drugs-- both for commercial and personal use -- and the assurance that those imports would be safe andeffective. An underlying goal is to reduce or restrain the growth of the financial burden thatprescription drugs place on U.S. consumers. Current law bars importation unless the Secretary of Health and Human Services (HHS)certifies that imports are safe and offers cost savings to U.S. consumers. Congress reaffirmed thisrequirement, first established by the Medicine Equity and Drug Safety (MEDS) Act of 2000, mostrecently in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA, P.L.108-173 ) in December 2003. (1) The three bill pairsare:
The Pharmaceutical Market Access Act of 2005 : S. 109 ,introduced by Senator Vitter on January 24, 2005, and H.R. The Safe Importation of Medical Products and Other Rx Therapies Actof 2005, or the Safe IMPORT Act of 2005 : S. 184 , introduced by Senator Gregg onJanuary 26, 2005, and H.R. The Pharmaceutical Market Access and Drug Safety Act of 2005 : S. 334 , introduced by Senator Dorgan on February 9, 2005, and H.R. All three bills haveextensive registration requirements. Whilecurrent law relies on laboratory testing of samples of every shipment of imported drugs to verify theircontent, potency, and labeling, the three proposed bills focus on documentation of a monitored,uninterrupted chain of custody from manufacturing facility to importer. Internet Pharmacies. Administration of Importation Provisions

The timing and funding of importation activities vary across current law and the proposedbills. The bills would require that these fees be used only for the administration of the importationprovisions that the bills would add. Effective Dates

Current law does not specify when importation could begin, other than linking it to therequired safety and cost certification by the Secretary. It also states that the importation provisions shall "permit theimportation of qualifying drugs â¦ without regard to the status of the issuance of implementingregulations" from registered exporters 90 days after enactment and from permitted countries byregistered importers one year after enactment. Comparison of Prescription Drug Importation Provisions in Current Law, S. 109/H.R. 328,S. 184/H.R. 753, and S. 334/H.R. 700
As prices of prescription drugs have risen, many in Congress have sponsored legislation topermit the importation of FDA-approved drugs from less expensive foreign sources. In the 109thCongress, three pairs of bills have been introduced to repeal the existing import restrictions andprovide for limited forms of importation of prescription drugs. Current law and the bills all seek tobalance the availability of imported prescription drugs -- both for commercial and personal use --and the assurance that those imports would be safe and effective. An underlying goal is to reduceor restrain the growth of the financial burden that prescription drugs place on U.S. consumers.
The drug importation provisions in the Medicare Prescription Drug, Improvement, andModernization Act of 2003 (MMA, P.L. 108-173 ) effectively do not allow the commercial orpersonal-use importation of prescription drugs. Congress, with the MMA, continued the major legalobstacle to importation: the requirement that the Secretary of Health and Human Services firstcertify that imports are safe and offer cost savings to U.S. consumers -- something no Secretary hasbeen willing to do. This report, which will be updated, briefly discusses major differences amongcurrent law and the introduced bills, and presents a side-by-side comparison of their provisions. Thebills are the Pharmaceutical Market Access Act of 2005 ( S. 109 , H.R. 328 ),the Safe Importation of Medical Products and Other Rx Therapies Act of 2005 (the Safe IMPORTAct of 2005; S. 184 , H.R. 753 ), and the Pharmaceutical Market Access andDrug Safety Act of 2005 ( S. 334 , H.R. 700 ).
Although all three pairs of bills seek to make lower-priced prescription drugs available toU.S. consumers by allowing importation while also ensuring that the drugs are safe and effective,they take different approaches. The proposed bills use extensive registration, licensing, facilityinspection, and records requirements to document an imported shipment's chain-of-custodyrequirements, rather than the MMA's use of mandated laboratory testing of imported drugs to verifytheir content, potency, and labeling. Current law and the bills each have different lists of countriesfrom which imports could be imported, and they provide the Secretary with different time framesand criteria for determining whether to permit commercial or personal-use importation. Secretarialreporting requirements vary as do mechanisms to fund the import activities: current law relies onappropriations alone, while the proposed bills each create specific user-fee provisions. The proposedbills also address the regulation of Internet pharmacies. S. 109 / H.R. 328 and S. 334 / H.R. 700 propose links to patent law to influence industrybehavior. While current law does not specify when importation could begin, S. 109/H.R.328 requires regulations to allow personal-use and commercial imports 180 days afterenactment. S. 184 / H.R. 753 provides for personal-use imports atenactment and commercial imports one year later. S. 334/ H.R. 7000 beginsimports from registered exporters 90 days after enactment and by registered importers one year afterenactment.