Eye on Washington

July 1, 2003

Although outbursts of lethal violence in Iraq, Israel, and Afghanistan last month continue to threaten the peace of the world, attention in the nation's capital focused on domestic concerns.

Although outbursts of lethal violence in Iraq, Israel, and Afghanistan last month continue to threaten the peace of the world, attention in the nation's capital focused on domestic concerns. Presidential primaries are not many months off, and candidates are intent on establishing a record that voters will find impressive—preferably before the July 4th congressional recess. Republicans seeking to retain the presidency and gain control of both houses of Congress are eager to pass legislation that seems friendly to families and the elderly—which accounts for the attempts to reinstate child tax credits for working families that they had cut out of earlier tax legislation, and to include a prescription drug benefit in Medicare. All this while retaining the tax cuts President Bush boasts of and keeping the ballooning federal deficit from getting any more attention than is necessary. Making all this a reality will take a great deal of bargaining among Republican Party leaders and in conference committees, and in the days leading up to the recess the outcome was far from certain.

Although presidents have to bargain with legislators, they usually make their wishes known with greater success within administrative agencies. Recent cases in point, of particular interest to pediatricians and parents, include:

  • Changing the rules on patents and generic drugs, to cut down on opportunities for pharmaceutical manufacturers to keep generic drugs off the market by charging patent infringement. A new rule promulgated by the Food and Drug Administration (FDA) will limit drug companies to only one, 30-month "stay" of the entry of a generic drug into the market in order to resolve a patent challenge. The FDA is also making changes in its review process to speed up safety and efficacy testing of generic drugs.

  • Rewriting the definitions of eligibility for college loans, with the overall effect of cutting federal costs by denying financial aid to some previously eligible college students. The changes, made by the Department of Education without any public input, are expected to reduce the government's contribution to higher education by millions of dollars, tighten access to federal aid for institutions, and shrink the pool of eligible recipients.

  • Prohibiting the importation and sale of animals or animal products that have been shown to spread human disease (such as prairie dogs and Canadian beef; see When animal diseases make the leap to people).

  • Preparing to make information about medications more accessible to the public, at an information site for consumers called Drugs@FDA. The site will catalog FDA-approved products, both prescription and over-the-counter, and will include generics and biologics. The site is due to come online in October.