A growing number of governors say they intend to defy federal regulators and purchase lower-cost prescription drugs from Canada. But the Bush administration is pushing back, stepping up enforcement against illegal and potentially dangerous imported drugs.
On September 29, the Food and Drug Administration (FDA) announced that an examination of 1,153 mail parcels destined for the U.S. from other countries revealed 1,019–nearly 90 percent–contained medications that violated U.S. drug safety laws. The majority contained drugs of unknown quality and originated from Third World countries.
In July 2003, Springfield, Massachusetts launched a program encouraging the city’s 20,000 employees and retirees to fax their prescription drug orders to a group of Ontario pharmacies and get their medications by return mail. The city expected to cut drug benefit spending by $4 million.
To test the safety of Springfield’s program, FDA officials ordered drugs, including insulin, from Michigan-based CanaRx under an assumed name and address. Insulin is a particularly good test case because it loses effectiveness at higher temperatures and is supposed to be shipped overnight to ensure it remains chilled. According to Peter Pitts, associate FDA commissioner for external affairs, the drugs arrived in the regular mail and at room temperature.
The Real Issue
Canada, where government-mandated price controls lower drug costs, takes in $1 billion a year for prescription drug purchases from U.S. consumers alone. Thanks largely to the Internet, Americans are buying more drugs than ever before from Canada and at least 25 other countries, including Austria, China, Ireland, Italy, Israel, and Mexico.
The FDA repeatedly warns such drugs raise serious safety concerns: They could be counterfeit, contaminated, expired, mislabeled, or mishandled. The agency won’t vouch for the quality of imported foreign drugs or those sold over the Internet, since there is no way to determine the origin of the drugs, their quality, their effectiveness, or if they endanger health.
No one disputes the fact prescription drugs are more expensive in the U.S. than in other countries–a consequence, in part, of the massive investment in research and development made by U.S. pharmaceutical manufacturers. Other countries essentially free-ride off U.S. pharmaceutical innovations and protections for intellectual property rights, leaving Americans to foot most of the bill.
The debate over drug importation and the higher price of prescription drugs in the U.S. has distracted the public, however, from a very important issue: the health risks counterfeit medications pose to Americans.
Consider these documented examples:
- Turkey, 1993: A pharmacist tries to sell baking powder to a patient as a genuine prescription drug. He is arrested by police.
- Haiti, 1996: At least 88 children die after taking counterfeit antipyretic syrup for relief of pain and fever.
- Lebanon, 1998: Interpol, the international police agency, says an immense factory in the Bekaa Valley may be the world’s largest producer of counterfeit medication, including Viagra. An Israeli Health Ministry spokesperson told the Jerusalem Post, “According to experts, 80 percent of the Viagra sold world-wide on the black market is not the real drug. What is ironic is that the black-market pills cost twice the price of Viagra gotten by prescription.”
- Kansas City, 2002: Authorities arrest a local pharmacist for diluting cancer drugs given to hundreds of patients while selling the medications at full price.
- Florida, 2003: Concerns about the safety of drugs surfaced after prosecutors announced a grand jury had indicted 19 people on charges of watering down or selling fake prescription drugs to businesses selling prescription medications to consumers. The drugs are often prescribed for AIDS and cancer patients.
- Nebraska, 2003: A counterfeit version of Pfizer’s Lipitor, the world’s top-selling cholesterol-lowering medication, was recently discovered after pharmacists and patients complained their medication tasted unusually bitter and dissolved too quickly. At least six lots of 90-count bottles containing 10 mg or 20 mg tablets have been recalled because they may contain counterfeit medication.
Hank McKinnell, chairman and CEO of Pfizer, said, “While the evidence available suggests that the counterfeit Lipitor is in limited distribution, American consumers need absolute certainty that the pharmaceutical distribution system will protect them from counterfeit products.”
- New Jersey, 2003: As part of the FDA’s efforts to investigate rapidly growing counterfeiting activities, FDA’s Office of Criminal Investigation uncovered the existence of contaminated Procrit, a drug used to stimulate the production of red blood cells in humans with severe anemia.
As a result of investigative review and laboratory testing performed by the FDA, and in cooperation with Ortho Biotech Products, L.P., medical professionals and consumers are being alerted to the existence of three lots of the counterfeit product labeled as Procrit (epoetin alfa). The firm issued a warning by letter and on its Web site (http://www.procrit.com/counterfeit/letter.html) because counterfeit Procrit has been found to be contaminated with harmful bacteria. FDA testing also demonstrated some of the counterfeit product contains no active ingredient at all.
In March 2000, the FDA announced that Janssen Pharmaceutica, a wholly owned subsidiary of Johnson & Johnson, would discontinue the sale of Propulsid (cisapride) in the United States. Use of the drug has been associated with 341 heart rhythm abnormalities, including 80 deaths. The drug was used as treatment for severe nighttime heartburn in adult patients with gastro-esophageal reflux disease.
The drug remains available for sale, often without a prescription, on Internet drugstore sites.
Consumers who buy prescription drugs across borders or over the borderless Internet have no assurances those drugs are safe … or even that they will get the exact drug their doctor prescribed. No foreign source of prescription drugs accepts responsibility for harmful effects or deaths from imported drugs.
The online prescription industry developed to fill perfectly legitimate needs, chief among them increased convenience and lower costs for consumers. But counterfeiting, criminal intent, deliberate misrepresentation, and patent and trademark infringement are reason enough to distrust any imported prescriptions.
Even though prescription drugs are tightly regulated at the legitimate manufacturing level and the legitimate pharmacy level, there exists a huge system operating mostly under the radar screen: drug distributors.
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which represents state regulators, told the Wall Street Journal, “There’s not the tight regulation [on drug distributors] they have on either end of the spectrum. It’s certainly a regulatory gap.”
Federal regulators haven’t always noticed what happens to drugs on their way to legitimate pharmacies, much less unregulated storefront operations, borderless pharmacies, or Internet drugstores. Drug distributors are primarily overseen by the states, and a 1988 federal law to toughen regulation hasn’t been fully implemented.
The increased reporting of cases of tampering and outright counterfeit medicines showing up in imported as well as domestic drugs is putting drug distributors in a bright light. According to the FDA, for example, the 200,000 bottles of counterfeit Lipitor found in Nebraska managed to pass through the hands of dozens of distributors, undetected as counterfeit.
In 2001, 6,500 or more drug wholesalers/distributors operated domestically in the United States. Today, the business is dominated by the top three: AmerisourceBergen, Valley Forge, Pennsylvania; Cardinal Health Inc., Dublin, Ohio; and McKesson Corp., San Francisco, California. They make up the “primary” wholesaling and distributing market.
A “secondary” market also exists, represented by distributors who often buy and sell pharmaceuticals among themselves. This market includes much smaller firms with a narrow customer base or product focus. The role of these mini-distributors has been advanced by the economics of the drug industry, where manufacturers often charge different prices for the same drug, as would be the case in selling drugs to a state Medicaid program, non-profit hospitals, or community health clinic.
The tampering, counterfeiting, and other criminal activity described here raises questions about drug distribution and its regulation. In most cases, perfectly safe drugs leave an easy-to-follow paper trail from a legitimate manufacturer to a legitimate wholesaler to a legitimate neighborhood pharmacy. Sometimes the trail goes directly from the manufacturer to a pharmacy, hospital, or other licensed health care provider.
In other cases, though, the trail gets cold, and medicines may pass through several wholesalers and unregulated storefront and Internet operations. These outlets may have no information about the origin, quality, or safety of the drugs they are selling to consumers. It is not impossible for a manufacturer of bogus drugs to create its own distributor.
The World Health Organization estimated in 2000 that about 8 percent of bulk drugs imported to the United States are counterfeit, unapproved, or substandard. The FDA has told Congress it has little information about such shipments. According to FDA officials, it would require hundreds of millions of dollars, years of planning, and additional staff to monitor the large-scale importation being suggested by Illinois Governor Rod Blagojevich and others.
Loopholes in current federal and state regulations make it difficult to follow the drug trail. Some states erect few barriers against setting up shop as a wholesaler, and no nationally applicable law requires distributors to document a drug’s origin or quality as it makes its way to the consumer.
Although the FDA does not prosecute individuals who buy imported medications, it has begun court action against Rx Depot, a chain of storefronts that facilitates drug purchases from Canada. The agency also has mounted a vigorous campaign against legislation that would legalize buying drugs from Canada and Europe.
FDA Senior Associate Commissioner William Hubbard said in a telephone briefing that H.R. 2427–the Pharmaceutical Market Access Act of 2003, sponsored by Representative Gil Gutknecht (R-Minnesota) and Rahm Emanuel (D-Illinois)–would make things worse. He said the anti-counterfeiting packaging envisioned in the bill does not exist and legalizing any type of drug importation would, according to Hubbard, “open up the floodgates to many more of these drugs and encourage people to go buy drugs no one had any regulatory oversight over.”
Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].