Since the 111th Congress has gotten underway, there have been a host of new and recycled bills that have been proposed. This probably only reprsents the tip of the iceberg of the types of reforms that are aimed at both the FDA and the industry itself.
- Prescription Drug Importation – Congressman Ron Paul would like to address the costs of prescription purchases with HR 163 – the Prescription Drug Affordability Act – which would amend the IRS Code so that retired persons could take a larger tax deduction for the purchase of prescription drugs and to facilitate the importation of prescription drugs. On the Senate side, Senator David Vitter has proposed S.80 – the Pharmaceutical Market Access Act – which would allow the Secrtary of HHS to issue regulations that would allow the importation of pharmaceutical drugs. The language in this bill is quite hostile to the pharmaceutical industry.
- Clinical Trials – HR 716 – Access to Cancer Clinical Trials Act – introduced by Congressman Steve Israel, would require group health and individual insurance policies to cover the expenses of individuals participating in a cancer clinical trial.
- Food and Drug Administration Reform – HR 759 – The Food and Drug Administration Globalization Act proposed by Congressman John Dingell would put into place new safety actions by the FDA on broad fronts, including both food and drugs.
- Recalls – Under this bill introduced by Congresswoman Betty Sutton, HR 841 – the Protect Consumers Act – the Secretary of Health and Human Services would have the power to order a recall of any product regulated by the FDA. Most people might think that such a power exists now, but it does not.
- Cardiovascular Research – Rep. Lois Capps has introduced HR 1032 – Heart Disease Education, Analysis Research and Treatment for Women Act – aiming to improve the status quo with respect to heart disease and women by empowering the FDA to consider an NDA incomplete without clinical data that relates to women. There is a companion piece of legislation in the Senate –S.422, proposed by Senator Debbie Stabenow.
- Generic Drugs – Rep. JoAnn Emerson has introduced HR 573 which would prohibit the marketing of authorized generic drugs.