Study Asserts that FDA’s Inefficiencies Delay Patient Access and Raise Costs of New Medical Technologies

President and CEO of the Advanced Medical Technology Association (AdvaMed), Stephen J. Ubl, released a statement on November 18, 2010, on a new study that evaluates the impact of device regulation on continued medical innovation.

 

Ubl describes the study as a wake-up call for those who want to promote medical innovation and preserve American jobs. The United States is the leader in the development of innovative medical technology, saving lives in US and around the world. Innovative medical technology contributes significantly to national economy. The study, conducted by Dr. Makower, remarks that inefficiencies thwart timely patient access to new technologies and industry competitiveness. A regulatory environment characterized by needless delays and inefficiencies makes it harder for medical innovation to grow and companies to survive. These delays particularly affect small companies and their ability to produce next generation technologies. Ultimately waiting patients and their physicians are denied access to these new technologies.

 

AdvaMed supports efforts aimed at honing reviewer and manager training, developing specific guidance for product types, improving the de novo process and defining specific metrics to improve consistency. Ubl urges the FDA to review the findings of the study. AdvaMed will work with the FDA to address the issues highlighted by the study.

 

Incidentally, a patient-advocacy group sued U.S. Food and Drug Administration officials for withholding approval of a genetically engineered prostate-cancer drug called Provenge. The plaintiffs claimed that the drug was safe and effective, and the denial of approval by FDA resulted from political conflicts within the agency. The lawsuit, filed by Dublin, an Ohio-based nonprofit organization, in a federal court in Columbus, also accused the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy. Prostate cancer patient advocates and Dendreon investors cheered when an FDA advisory panel made encouraging comments about Provenge in March. But two months later, the agency decided to seek more data, potentially delaying the drug's launch for years. The stock, which had rocketed to USD 23.58 from around USD 5 after the panel recommendation, hit rock bottom.

 

Advocates of prostate-cancer patients are not the first to sue the FDA to force it to accord speedier approval. In the late 1980s, HIV-patient groups too used similarly aggressive tactics and eventually succeeded in getting the agency to fast-track certain therapies.

 

In 2003, the Abigail Alliance for Better Access to Developmental Drugs sued FDA seeking better availability of early-stage therapies for terminally ill cancer patients. That suit was dismissed, and then reinstated, for review by a U.S. Court of Appeals for the District of Columbia.

 

Patients' demand for easing controls on drugs for terminally ill patients has provoked a similarly intense campaign for stricter regulation. Recent safety scandals about drugs that once received the FDA's approval have resulted in calls for tighter supervision and effective legislation in order to strengthen the agency's role.

 

 http://www.qmed.com/news/26517/new-study-finds-inefficiencies-fda-delay-patient-access-increase-costs-new-medical-techno