2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC60
Submitter : Mr. David Seaver Date & Time: 06/03/2004 04:06:25
Organization : Massachusetts Soc. of Health-System Pharmacists
Health Professional
Category :
Issue Areas/Comments
FDA's Ability to Assure Safety
6. What should FDA do to assure safety of imported products?
(Continued from above)
(?Insurer won?t cover doctors for Net Drug Lawsuits,? Winnipeg Free Press, Jan. 6, 2004).

The Health Canada system provides the approval process for getting medications onto the market in Canada. Though not identical to the FDA, they are similar enough to be considered equivalent to the FDA. Heath Canada approved drugs are usually as safe as FDA approved drugs. There are differences however. Propulsid, a medication that has been linked to over 300 deaths worldwide and pulled from the US market in 2000, is still available in Canada and through Internet pharmacies. Opening the American market to Canadian pharmacies and medications open it to all medications available in Canada, whether these medications have been approved for use by the FDA or not.

MSHP believes that other means of reducing the cost of prescription medications should be explored ? that reimportation is NOT the answer.

The State of Maine and its Maine RX program has negotiated rebates and other drug discounts from drug manufacturers. If a drug manufacturer does not participate in the program, its medications for any Maine Medicaid patient are subject to the prior authorization process. This program has allowed Maine to provide affordable prescription medications to its citizens without resorting to foreign pharmacies.

Generic medications available in the US, less expensive than both Canadian brand and generic medications, are underutilized. In a study published in the Journal of American Medical Association, generic medications were shown to be as effective as brand name drugs in treating one of the most common disease states, hypertension. The study concludes that for many people, a type of diuretic known as thiazides is superior to angiotensin- converting enzyme (ACE) inhibitors and calcium antagonists (calcium channel blockers) in preventing one or more major types of cardiovascular disease. The diuretics also tend to have fewer and less severe side effects, making it easier to stay on your medication. In addition, the diuretics cost less, anywhere from six to twenty times less. (ALLHAT Collaborative Research Group. Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), JAMA 2002; 288(23): 2981-97).

In closing, MSHP urges the FDA to continue its current policy on reimportation, and urge the Secretary not to allow imported drugs into the United States. MSHP stands ready to assist the FDA in developing a rational and coordinated approach to providing safe and cost effective medications. Feel free to contact me 617-732-7677 if you need any additional information.

Sincerely,


David Seaver

Chair, Legislative Committee
Massachusetts Society of Health-System Pharmacists
500 West Cummings Park
Suite 3475
Woburn, MA 01801-6585
dseaver@partners.org

Barbara Irby

President
Massachusetts Society of Health-System Pharmacists
500 West Cummings Park
Suite 3475
Woburn, MA 01801-6585
birby@partners.org

1. What should FDA do to assure safety of imported products?
6/1/04

Dr. Lester Crawford
Acting Commissioner
Food and Drug Administration
Divisions of Dockets Management (HFA-305)
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

Re: Docket No. 2004N-0115

Dear Dr. Crawford:

On behalf of the Massachusetts Society of Health-System Pharmacists (MSHP), we are writing to express our concerns regarding docket No. 2004N-0115, regarding Canadian Medication Reimportation. MSHP is a professional society representing the interests of 900 institutional based pharmacists in Massachusetts.

Some Commonwealth communities have begun to reimport medications from Canada in an attempt to ameliorate the expense of prescription medication cost to those communities. Notably, the city of Springfield, Massachusetts has begun its Canadian medication reimportation program despite the fact the program runs in direct violation of federal law. The FDA may take action and shut down this program (?Boston to Defy Rules on Drug Imports,? Financial Times, Dec. 10, 2003).

In 1987, Congress expressly banned medication reimportation citing concerns that reimported drugs ?are a health and safety risk to American consumers because they may have become sub potent or adulterated during foreign handling and shipping,? and because they provide ?cover for the importation of foreign counterfeit drugs.? (Prescription Marketing Act of 1987, P.L. 100-293, Sec. 2.) The potential for counterfeiting is high. The FDA does not have the opportunity to track these reimported medications. As the FDA testified before the Special Senate Committee on Aging, ?Opening our boarders to reimported drugs could potentially increase the flow of counterfeit drugs, cheap foreign copies of FDA approved
drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. In the light of the recent anthrax attacks of last fall, that?s a risk we simply cannot take.? (Testimony of William Hubbard, FDA Senior Associate Commissioner for Policy, Planning and Legislation, before the Special Senate Committee on Aging, July 9, 2002).

The FDA conducted a study on the safety of reimported medications from Canada. The FDA identified ?serious public health risks? associated with ?many? of the intercepted medications. The risks included ?drugs of unknown origin or quantity? and drugs dispensed without a prescription or without continued oversight of a physician.? (Id.) This study convinced the FDA that it could not trust the safety of drugs imported by mail.

The Canadian Healthcare System is also responding to the reimportation issue. Canada has doubled its imports of prescription drugs in the last five years and would be unable to meet the demand created if U.S. law allowed greater access. (US Drug Needs Would Overwhelm Canada Report Attempts to Show Impact if Cross-Boarder Access, Julie Appleby, USA Today, May 17 2004). A study by UT-Austin researcher Marv Shepherd finds that if all US residents bought their medications from Canada, Canadian supplies would be exhausted in 38 days; that if half of US elderly were to buy from Canada, it would have to increase supply 2.5 times; and 56% of the medications on the Canadian market are themselves imported from countries other than the US, including some from developing nations (Id.).

Also, the Canadian International Pharmacy Association, the largest representative of the Canadian pharmacy importers, announced its 27 members would not provide prescription drugs for state and local governments (?Canada Cools to U.S. Drug Flow,? Wall Street Journal, Dec. 26, 2003). The Canadian Medical Malpractice provider, Canadian Medical Protective Association, will be denying medical malpractice coverage for doctors sued over Internet prescription drug transactions in Canada. Canadian physicians that rewrite U.S. prescriptions will be unable to procure malpractice insurance, a key requirement of many Canadian provinces for a physician to be licensed (cont.)