The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) passed by Congress in December 2003 directs the Secretary of Health and Human Services (HHS) to lead a comprehensive study on drug importation and its potential impact, both positive and negative, on the health of American patients. As a result, the FDA created a task force to study this issue and is due to report its findings back to the Congress no later than December 2004.

  • On April 8, Senate Finance Committee Chairman Charles E. Grassley (R-IA) introduced legislation called the Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards (REMEDIES) Act of 2004 (S. 2307).


  • This would immediately open the door to Americans who buy prescription drugs from Canada and would require the FDA to create a system to allow individuals, pharmacies, and drug wholesalers to legally import prescription drugs from registered foreign exporters.


  • On April 21, a bipartisan group of Senators introduced the Pharmaceutical Market Access and Drug Safety Act (S. 2328) to legalize both personal and commercial importation of prescription drugs from Canada and later from the European Union and other nations with “advanced drug regulatory systems.”


  • S. 2328 would allow consumers with legal prescriptions to immediately begin importing 90-day supplies of prescription drugs from FDA-approved Canadian pharmacies. The list of approved pharmacies would be published on the FDA website. Additionally, the bill would allow pharmacists and wholesalers to begin purchasing drugs from Canada within 90 days after enactment.
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  • If passed, this bill will require wholesalers and pharmacies importing drugs to register with the FDA and would assess levy fees on the importer to pay for increased safety and quality assurance monitoring by the FDA. Importers would also have to provide a full chain-of custody (pedigree) to track movement of the drug from the manufacturer to the sale to the consumer.
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    The Grassley REMEDIES Acts and bipartisan proposal are similar in terms of identifying allowed importers and what’s allowed to be imported. The key distinctions between the two proposals are related to:

  • The means used to prevent manufacturers from circumventing importation by cutting supplies to foreign pharmacies that import product back into the US or through product alteration. – The bipartisan bill requires drug manufacturers to notify the FDA of any manufacturing changes that might serve to circumvent importation. Grassley’s bill uses tax credits and penalties to encourage manufacturers to accept legalized importation


  • The financial resources obligated to fund FDA’s increased involvement with imported drugs. – The bipartisan bill requires domestic importers to register with the FDA and fund the agency’s enforcement efforts through user fees; Grassley’s bill would certify and charge the foreign exporters

  • Timing
    – The bipartisan bill opens the US market to drugs from the European Union quicker. The FDA has raised continued concerns with these new importation schemes. In particular, the FDA notes that the bipartisan
    		•   bill appears to place a new burden on them without providing requisite resources to ensure that drugs entering the US are safe. The FDA continues to be concerned that this could provide channels for counterfeit or improperly stored products to enter the US market. FDA officials claim the bill would also cause them to expend significant resources to deal with an onslaught of applications for minor drug formulation changes, including changes in drug color or a salt that would not change the intended effect of the drug.

    Medicare Beneficiaries May Enroll in Drug Discount Programs in May; CMS will Provide Drug Price Comparisons on Medicare Website

    Beginning on May 1, 2004, Medicare beneficiaries are now able to choose a drug discount card which the Centers for Medicare & Medicaid Services (CMS) expects will save these consumers from 10 to 15 percent of their overall prescription drug costs.

  • CMS has endorsed 48 general drug card programs (27 of these are national programs), and Medicare beneficiaries will have a choice of at least two drug cards where they live.


  • Drug Discount Card programs will have a standardized enrollment form provided by CMS, and each card program can require an enrollment fee not to exceed $30.

  • Low-income Medicare beneficiaries can also receive a $600 credit toward their prescription medications, and they will not be charged an enrollment fee. Medicare beneficiaries without access to the Internet can obtain the same comparative information by calling 1-800-MEDICARE.
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    Congratulations to Cathy Hansen on her recent appointment as a member of ASHP’s Council on Legal and Public Affairs. Nominated by NJSHP, Cathy is the second NJSHP member to be appointed to an ASHP post (Eric Hola was NJSHP’s first member appointed to the Council of Organizational Affairs and he is now ASHP Chair of the Board of Canvassers.)

    The Council on Legal and Public Affairs is concerned with laws and government administrative regulations, proposed laws and regulations, and pharmacy ethics. ASHP members have    		   many opportunities to identify topics for policy development via open hearings, regional delegate conferences and through the House of Delegates in the form of Recommendations, Resolutions and New Business. In her one year role, Cathy and her peers will help review position statements, resolutions, and papers that have been submitted from ASHP members nationwide.

    There’s an annual meeting in September in which this council as well as four others meet for two days of thoughtful deliberations. Each    		   council submits a report with policy recommendations that are acted upon the Board of Directors in November. Proposed new professional policies must be approved by the Board of Directors before they are submitted for House of Delegates action. The House of Delegates convenes annually at ASHP’s Summer Meeting. This meeting constitutes the culmination of the year-long policy development process that drives ASHP’s pursuit of its vision for hospital and health-system pharmacy.

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