The National Medicare Prescription Drug Congress: The FDA Perspective

23 May

The second day of the conference continued with more government perspectives on the effect of the MMA. FDA Commissioner Mark McClellan, newly nominated by President George W. Bush to head the CMS, stated that many senior citizens are considering gambling on the safety and effectiveness of their medications (i.e., buying re-imported medications) because they have grown tired of skipping doses and cutting pills. In essence, it has become a battle between safety and affordability. As stated earlier, the FDA cannot ensure the safety of medications ordered from outside the U.S. Dr. McClellan notes that the FDA has the duty to verify safety and the opportunity to lower drug costs while maintaining the integrity and legality of medications. Although Americans pay for half of the cost of all prescription drugs worldwide, the FDA is not sure whether it can certify that these medications are pure.

Like DHHS Secretary Thompson, Dr. McClellan cited a series of single pre-announced inspections of eight Internet pharmacies in Canada by FDA officials in Minnesota. The inspectors discovered widespread evidence of dozens of infractions, such as improper supervision by a pharmacist, improper storage of drugs, and labeling irregularities—”a true buyer-beware type of practice.” He also discussed the recently announced Wisconsin Web site for Canadian pharmacies, which describes, through various legal disclaimers, that the state of Wisconsin is not responsible for the practices or safety of the pharmacies listed on its Web site.

In order to answer how and under what circumstances reimportation can work, the FDA has established a task force that will hold at least five meetings to determine the viewpoints of a wide variety of stakeholders and the general public. The task force will comprise consumer groups, professional health associations, health care purchasers (employer groups, cities, and states), industry associations, and international stakeholders. In addition, open public meetings will be held to enable the general public to provide comments; there will also be an open public docket to accept comments on drug reimportation. All findings will then be presented publicly at a date to be determined.

Besides the re-importation issues, Dr. McClellan noted other attempts by the FDA to keep drug prices down, including the creation of larger generic drug programs and enhanced information technology. New reforms are being created to promote generic competition as soon as generic drugs are available. Citing CMS data, he said that the states spend 7% to 8% of their budgets for prescription drugs through Medicaid on medications that already have generic alternatives. He mentioned that in Illinois, 12 of 90 medications that are intended to be re-imported already have generics available that are less expensive than the brands that the state wants to import from Canada. The use of over-the-counter medications might be a way of lowering drug costs by as much as 30%.

He envisioned numerous initiatives by the FDA that should help reduce the costs of new medications but explained the difficulty of closing the gap when health insurance does not keep up with technology. Even with the advent of novel medications through new technologies, he believes that many American seniors cannot afford their prescribed medications.

Dr. McClellan thinks that technology improvements through electronic medical records are just around the corner because of the recent mandate of bar coding for all medications; however, the purchase of scanners to read the bar codes has not been mandated. (For more on this topic, see Stephen Barlas’ article on page 211.) Electronic prescribing (eRx) will enable information at the point of care to allow physicians to offer accurate dosing that will avoid drug interactions and side effects and to prescribe medications appropriately.
canadian pharmacy

The FDA has several initiatives to encourage electronic prescribing in addition to the provisions outlined in the MMA for demonstration projects on the subject. A new electronic label will be created to allow digital updating of medications daily. This information will build upon current pharmacy databases so that prescriptions can be reviewed more quickly and accurately.

Nevertheless, Dr. McClellan points out that these systems are only as good as the information that is placed into them. The challenge of the MMA will be to create, implement, and use this technology to benefit older adults as well as patients of all ages.