Rosa L. DeLauro Congresswoman a keynote speaker at the American Association for the Advancement of Science (AAAS) Conference “What Evidence is Essential for New Medical Products—Implications for Patients and Health Policy” on June 13, in Washington D.C., wants to see FDA strengthen some of their policies and funding for FDA increased.
The conference was held to review the growing body of research concerning the medical and public health implications of medical product approval criteria and to examine the findings in the context of patient outcomes, costs, and health policy.
Congresswoman DeLauro is encouraging evidence-based programs and policies to advance the frontiers of knowledge and determine what evidence is essential in producing drugs and prescription drugs that are based on scientific evidence. She emphasized the need to ensure that the FDA can regulate, test, and assure the safety of drugs used in hospitals, doctor’s offices, and homes across the country.
She is also working to ensure the safety and efficacy of the approval processes for medical devices as well as for improved safety standards, post-market surveillance, and appropriate classification and labeling of medical devices to protect patients and consumers.
A few months ago, Congresswoman DeLauro outlined her concerns in a letter to FDA Commissioner Margaret Hamburg on the issue of over accelerated drug approval. Specifically, she is concerned that FDA’s guidelines “Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need” might lower the standard from two well-designed controlled clinical trials to one smaller study that may not necessarily measure a meaningful health outcome.
In addition, DeLauro is also questioning if FDA permits smaller sample sizes, would it be feasible to conduct subgroup analyses for safety and efficacy in women and men, in different racial and ethnic groups, or across age groups?
In a statement accompanying the letter, DeLauro said,” The FDA has a high level of regulatory authority and discretion over medical device classification and drug approval methods so the
public puts their trust in FDA to ensure that drugs and medical devices are both safe and effective.”
For more information, go to http://delauro.house.gov