U.S. prescription drug legislation

The U.S. Congress has considered numerous pieces of legislation concerning the delivery of healthcare in the country. Prescription drugs became a key focus as their prices began to rise considerably in the latter part of the twentieth century. This page deals with efforts in Congress to regulate the process whereby citizens attain prescription drugs.

House
In early July, 2007, House Democratic leaders planned to pass the Food and Drug Administration Amendments Act of 2007 (H.R. 2900), a Food and Drug Administration overhaul measure that would reauthorize the agency’s program for approving new prescription drugs. The bill, sponsored by Sen. John Dingell (D-Mich.), would also create new drug safety regulations, including larger fines for violators. The bill was put on the suspension calendar, which would require it to have a 2/3 vote to pass. Usually, bills considered under suspension of the rules have widespread support and are easily passed.



A successful 2/3 vote, however, would send a strong message to the drug industry, the FDA and the Senate, which passed a weaker FDA reform bill in may of 2007. The placement under the suspension calendar indicates the bill's bipartisan support, as Democratic compromises during a markup of the bill brought out unanimous Republican support. House Republicans expressed surprise that the bill will be considered under suspension, but they said it probably would not prevent its passage. Considering the bill under suspension also bars amendments, which means riders that could threaten passage — such as allowing the importation of prescription drugs — can be avoided.

Senate
In May 2007, the Senate debated S.1082, a bill, sponsored by Sen. Ted Kennedy (D-Mass.), which would amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes. Specifically, it would:


 * Increase "user fees", those fees paid by manufacturers, for post-approval and pre-market testing of prescription drugs and medical devices. The fee would increase 8.5% in 2010 if the number of users fell below 12,500 in 2009. Devices for pediatric use and for humanitarian devices would be exempt from testing fees.
 * Improve the safety of drugs, and communicate to consumers potential adverse drug effects. Drug safety would be improved through routine active monitoring by a public/private foundation to be created under the bill’s Risk Evaluation and Mitigation Strategy (REM). The partnership would oversee trials and surveys both post-market and when safety signals are triggered. Safety signals come from reports of adverse events experienced by drug users. The private side of the partnership would be an entity that has a "significant business presence", research capabilities, drug development expertise and experience with drug development and risk balancing, sufficient Internet technology to manage that data and survey adverse events and can provide data security to insure privacy. The partnership would look to adverse drug events that range from reactions to use, to the drug not being effective, and to serious adverse drug events ranging from death to inability to live a normal life.
 * Allow the FDA to review direct to consumer prescription drug advertisements.
 * Form a public/private organization to oversee the drug safety process.
 * Establish the Reagan-Udall foundation to adapt the FDA mission to modernizing medicine, veterinary medicine, food ingredients, cosmetic products and product safety.

 The bill would require that state-legalized medical marijuana be subject to the full regulations for the FDA, including a risk evaluation and mitigation strategy.

Dorgan amendment to allow importation
An amendment, introduced by Sen. Byron Dorgan (D-N.D.), would allow drug importation from certain foreign countries (most notably Canada, where many Americans had already been purchasing drugs).

A vote on the amendment passed 63-28.



Allard amendment to strike provisions related to market exclusivity
If passed, this amendment would have removed provisions for limiting market exclusivity for companies that test their products on children. Specifically, this amendment would remove paragraphs (D) and (E) of section 402(a)(6).



Cochran amendment to protect the health and safety of the public
This amendment was considered by many to be a poison pill for the importation provision accepted above because it would require the Food and Drug Administration (FDA) to certify that imported drugs are safe. The FDA, however, had already said that it was bureaucratically impossible to do this. Meanwhile, President Bush indicated that he may veto the legislation if it did not resolve safety concerns.



Durbin amendment to ensure the safety of human and pet food
This amendment added provisions that would bolster "food safety operations" in the U.S. with regards to both human and pet food. It followed several incidents in 2006 and 2007, such as tainted spinach and peanut butter outbreaks.



Passage
On May 9, 2007, the Senate passed the final bill, 93-1. Sen. Bernie Sanders (I-Vt.) was the lone dissenting vote. Sen. Ted Kennedy (D-Mass.), the bill's sponsor, stated “This landmark legislation creates a stronger Food and Drug Administration and sets forth a new and better direction for the safety of the drugs we take and the food we eat.” Sen. Mike Enzi (R-Wyo.), a cosponsor, stated, “Today we have risen above partisan politics to deliver a monumental victory for all Americans.”



External resources

 * TheWeekInCongress