ASHP Opposes Pharmaceutical Market Access Act of 2003
The American Society of Health-System Pharmacists (ASHP) is adamantly opposed to legislation passed yesterday by the House of Representatives that would allow medications to freely move across U.S. borders without authorization or control by the U.S. Food and Drug Administration (FDA).
The Pharmaceutical Market Access Act of 2003, H.R. 2427, would allow individuals, pharmacists, and wholesalers to import pharmaceuticals with no limits as to the types of drugs allowed or frequency of their importation. Under this legislation, records would not have to be maintained by individuals who import medications, and the drug products would not have to be tested for authenticity or potency.
This bill is absolutely the wrong way to solve the important issue of medication affordability and accessibility in the U.S., said Henri R. Manasse, Jr., Ph.D., Sc.D., ASHP executive vice president and CEO. Allowing imported drugs to enter the country with the bare minimum in terms of safeguards will create significant safety hazards for patients who cannot know if the medications they are receiving are expired, contaminated, counterfeit, subpotent, or superpotent.
Manasse went on to say that drug importation without FDA oversight will likely create serious breaks in the integrity of the nations medication supply chain. Recent instances of counterfeit medications that endangered public health include fake Lipitor, a drug used to treat high cholesterol, and Procrit, a medication that boosts red blood cells for patients with anemia associated with treatments for cancer and chronic renal failure. These drug products were distributed under the current system of FDA oversight.
Counterfeiting is quite common in countries outside the U.S. that dont have the strict drug controls we have here, Manasse said. This legislation will essentially open the U.S. market to anyone outside the country who is actively involved in manufacturing fake drugs.
ASHP is strongly urging its members to oppose this legislation to help protect the safety and integrity of the nations medication supply.
ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, ambulatory care clinics, long-term care facilities, home care, and other components of health care systems. ASHP, which has a long history of medication error prevention efforts, believes that the mission of pharmacists is to help people make the best use of medicines. Assisting pharmacists in fulfilling this mission is ASHPs primary objective. The Society has extensive publishing and educational programs designed to help members improve their professional practice, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs. For more information, visit ASHPs Web site, www.ashp.org, or its consumer Web site, www.safemedication.com.