FDA and Fake Drugs - Fact or Fear?

Evidence?

Some may question how FDA defines “counterfeit,” as there are allowable variances in active ingredients from batch to batch from brand-name manufacturers, and also when comparing generics and brand names.

“They have not shown any evidence in that report that the accusations have validity,” said Mr. Troszok, an on-line pharmacist and past president of the Canadian International Pharmacy Association. “Our organization is asking for clarification on this issue before we make any generalized statements.”

Instilling more fear?

David MacKay, a consultant for more than a dozen Canadian on-line pharmacists, shared Mr. Troszok's skepticism. He pointed to the FDA's long-standing opposition to the trade and says it has a pattern of trying to instill fear in the U.S. public about legitimate Canadian drugs.

Testing Methods?

“We have absolutely no indication of the methodology of their testing, or the country of origin,” said Mr. MacKay, a consultant for more than a dozen Canadian on-line pharmacists. “There is a potential this may not be on the up and up.” Mr. MacKay said in recent weeks there been increased buzz among U.S. opponents of the industry about the threat of counterfeit.

Canadian Pharmacies Take the Heat!

The Canadian industry has lost much of its steam in the last 18 months due in large part to the strong Canadian dollar and blacklists by brand-name drug manufacturers that have driven many Internet pharmacists to get their drugs from overseas suppliers. These blacklists are created when a large Pharmaceutical company in the U.S. who makes the same drugs for Canada puts the squeeze on Canadian Pharmacies by choosing to sell limited quantities to Canada thus allowing U.S. Pharmacies to make more when Canada runs low or completely out (which has not happened yet). This mentality hurts Canadians and U.S. buyers as more and more online pharmacies will choose outsourcing to other international companies to fill that gap created by U.S. Pharmaceuticals who insist on being the only choice.

Is it coincidental when for the past year seizures have risen, scare tactics have been initialized, and now fake drugs have been found? What surer way to keep Americans buying American, and Plan D in check.

What do they care?

"Part D seems to be impacting the whole industry," said Betty Sanna, Verispan's product director of managed care. "It's absolutely important to these companies." After a bumpy start to the program, Medicare Part D has had a pronounced effect on pharmaceutical companies' financial results, with a majority of U.S. pharmaceutical revenues in the second-quarter exceeding Wall Street expectations.

But experts caution that the upside to U.S. pharmaceutical earnings may not last. As the financial costs of maintaining the benefit rise (Plan D), plans may limit choices to products that are the best value for the money, and many payers will implement generic-only formularies, allowing access to branded medicines only after a generic drug has failed.

How 10 Largest Drug Firms Benefit From Medicare Part D

Some of the biggest pharmaceutical companies are generating a higher proportion of sales from their drugs' participation in the Medicare Part D prescription drug program. The companies are ranked by U.S. retail sales.

% Part D prescriptions-Biggest Company-January-July 2006-Part D Drug

1. Pfizer Inc. - 8.8 percent - Lipitor
2. GlaxoSmithKline P.L.C. - 7.7 percent - Coreg
3. AstraZeneca P.L.C. - 10.4 percent - Toprol XL
4. Novartis AG - 8.9 percent - Diovan
5. Merck & Co. Inc. - 10.9 percent - Zocor
6. Johnson & Johnson - 5.5 percent - Levaquin
7. Teva Pharmaceuticals - 7.6 percent - lisinopril
8. Sanofi-Aventis SA - 6.7 percent - Ambien
9. Eli Lilly & Co. - 9.5 percent - Evista
10. Bristol-Myers Squibb - 13.6 percent - Plavix


Reference:
pharmacist.com
theglobeandmail (Canada)

Informational articles gathered by
XLPharmacy Canada