Pfizer Goes On the Offensive

Feb. 16, 2005
Even before Peter Rost testified in favor of reimportation before a Senate committee, Pfizer SVP Chuck Hardwick had fired off this letter to Senate Committee Chairman Enzi, arguing that reimportation endangers the U.S. drug supply and the public.
Editor's Note: The following letter was sent by Pfizer Senior VP Chuck Hardwick to Senator Mike Enzi (Wyo.), the chairman of the Senate Committee on Health, Education, Labor and Pensions. The letter serves as a preemptive counterpoint to Dr. Peter Rost’s testimony to the committee.Dear Chairman Enzi:We understand that Dr. Peter Rost will testify today before the Senate Committee on Health, Education, Labor and Pensions on the subject of prescription drug importation. At the outset, it is important to note that while any citizen is entitled to speak before the Congress, Dr. Rost is not speaking on behalf of Pfizer. Dr. Rost has never been involved in the extensive analysis of this critical issue that has been undertaken at Pfizer. He has not participated in Pfizer’s active involvement in the government’s examination of this issue. These Pfizer activities include the following:
  • In April, Pfizer’s Vice President of Global Security, John Theriault, testified before the Department of Health and Human Services’ Importation Task Force, which was mandated by Congress to study the feasibility of importation. In May, Pfizer provided a submission to the Task Force that supports Pfizer’s position that foreign authorities do not have the controls in place to guarantee the safety of exported regulated drugs.

  • Pfizer also participated in the GAO’s study of drugs purchased online by helping determine whether these drugs are counterfeit. The GAO testified before a Senate subcommittee in June, concluding that consumers can easily buy drugs over the Internet without a prescription. The GAO concluded by stating, “It is notable that we identified these numerous problems despite the relatively small number of drugs we purchased, consistent with problems recently identified by state and federal regulatory agencies.”
In addition, we have no basis to support Dr. Rost’s purported expertise in this area. It has been a number of years since Dr. Rost was stationed in Europe and we believe that his knowledge is outdated. For example, he incorrectly suggests that the price differences exploited by parallel trade in Europe have been passed on as savings to consumers when virtually all objective analysis refutes that assertion.A study conducted by the London School of Economics, which was published last year, found that national health systems within the EU realized minimal savings from parallel traded products. In fact, the study showed that no single national payer saved more than 2.2% because of this trade despite wildly varying price discrepancies. In the UK, the study found that “The impact on patients in the UK from parallel trade is zero” and that prices of parallel imported products “are on average the same as those of locally sourced equivalents...”(despite average price differentials of more than 20%).Parallel trade in Europe involves trade between pharmacies and wholesalers subject to regulations in their respective home markets. It does not involve individuals importing medicines on their own from foreign jurisdictions. Our long experience analyzing parallel trade and considerable objective research shows the gains ultimately accrue to the middlemen rather than to consumers or payers.The issue of importation and how it may impact the safety of American patients is a serious health issue requiring informed debate. In 1987, Congress enacted important changes to prohibit the importation of unapproved medicines in response to many instances of unsafe foreign medicines entering the U.S. While the public health threats caused by such medications were significant enough in 1987, the potential threats from unapproved prescription drugs are even greater today.Here are a few key points that we believe need to be factored into the discussion:
  • Unapproved, unregulated and counterfeit medicines bought online can (and do) come from virtually anywhere in the world. In light of the counterfeiting activity Pfizer has investigated, the importation proposals we have seen in Washington and some of the states are truly alarming. These programs open a tightly regulated system to a new drug distribution channel in which virtually every participant operates outside the law, outside the standards of acceptable medical practice and without effective oversight.

  • In December 2003, the Minnesota Board of Pharmacy investigated eight Canadian Internet pharmacies and found 32 different unsafe or questionable pharmacy practices (on pre-arranged visits!), including unsupervised technicians performing pharmacist functions; shipping multiple labels unattached from multiple prescriptions in the same box; incomplete patient profiles; returned products re-labeled and resold; and unsafe storage and shipping, particularly of temperature-sensitive drugs. The Board investigators found that the standards followed by the Canadian Internet export operations varied greatly from pharmacy to pharmacy—some "appearing to have few standards at all."

  • A still larger concern is that consumers don't have any real idea about the true origin of the products. As the National Association of Boards of Pharmacy cautioned in its Position Paper on importation: "An order for what is purported to be a Canadian drug may never be filled by a legitimate Canadian pharmacy with a Canadian drug or even be filled in Canada. The well-known risks that all consumers take when purchasing over the Internet, where, for example, an anonymous company may be 'here today and gone tomorrow' or an illicit business is disguised as a legitimate organization, are heightened when purchasing foreign drugs."

  • This concern is echoed in Prevention magazine’s detailed review of Internet pharmacy practices: “Shoppers need to be aware of a deceptive tactic known as ‘hiding under the maple leaf’: Web sites that advertise themselves as Canadian or prominently display the familiar maple leaf flag but are actually registered elsewhere.”

  • The dangerous nature of the products being shipped from foreign Internet pharmacies across the American border is exemplified by recent spot examinations conducted by the FDA and U.S. Customs. These found many shipments containing dangerous, unapproved and counterfeit drugs that pose serious safety problems. An overwhelming majority of the parcels violated U.S. laws and regulations because they contained unapproved drugs.

  • Finally, a study by the head of the University of Michigan School of Public Health’s Department of Health Management and Policy warns that federal drug importation would result in the loss to the state of thousands of jobs, decreased availability of U.S.-discovered medicines around the world, and diminished patient health benefits as a result of reduced future availability of new medicines from an overall reduction in R&D.
The situation overseas is no better. Notably, in recent months the UK suffered two high-profile counterfeit cases involving fake medicines in the legitimate supply chain:
  • In August, a UK health care agency issued an alert recalling two batches of Lilly’s Cialis when counterfeits were discovered after a patient reported to Lilly that his 20mg tablets were crumbly.

  • In September, the same UK agency issued a second alert recalling a batch of Abbott’s Reductil after counterfeits were spotted by a wholesaler after it became suspicious of the batch number.
The extent of counterfeit medicines in the UK is unclear. However, at the end of 2000, the Centre for Economic Business Research claimed that six percent of the drugs in the UK were probably fake. Pfizer believes that international counterfeit operations are clearly targeting Europe’s legitimate supply system.We hope you will take this information and the issues they raise into consideration as your committee considers this important issue.Sincerely,Chuck HardwickSenior Vice President WorldwideGovernment & Public Affairs