Navigation Links
PhRMA Statement on Enactment of FDA Legislation
Date:9/27/2007

WASHINGTON, Sept. 27 /PRNewswire-USNewswire/ --- Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement today on the enactment of the "Food and Drug Administration Amendments Act of 2007:"

"By signing into law the 'Food and Drug Administration Amendments Act,' President Bush has taken a vital step to both strengthen our nation's drug safety system -- already the world's best -- and preserve crucial incentives to help spur research and generate critical information about the use of medicines in our children.

"The law, which reauthorizes the Prescription Drug User Fee Act (PDUFA), provides FDA with additional resources it needs to promote and protect the public health. The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems.

"FDA will have the capacity to modernize its Adverse Events Reporting System, which is used to collect and aggregate safety data, enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information, and better evaluate risk communication and risk management programs.

"The law also reauthorizes the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), both of which were set to expire on September 30. BPCA has done more to spur research and generate essential information about the use of medicines in pediatric patients than any other initiative and PhRMA has supported its reauthorization without significant modifications.

"Furthermore, the law will enable FDA to hire additional employees to review broadcast drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit such advertisements to the agency before airing them. This will complement improvements in advertisements that have already occurred as a result of PhRMA's Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs.

"Since its original enactment in 1992, PDUFA has been a resounding success for FDA, pharmaceutical research companies, taxpayers and, most importantly, patients. PDUFA has made timely review of new medicines possible without compromising FDA's strict and objective review process. As a result, more than 1,000 new medicines have been made available to patients over the past 15 years. These medicines have helped millions of people lead healthier, more productive lives, and contributed to a longer life expectancy than ever before."

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.

PhRMA Internet Address: http://www.phrma.org

For information on how innovative medicines save lives, visit: http://www.innovation.org

For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org

For information on the danger of imported drugs, visit: http://www.buysafedrugs.info


'/>"/>
SOURCE Pharmaceutical Research Manufacturers of America
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Doctors Seek Legislation To Protect Them
2. Spanish legislation Vote For Equality of sexes
3. China Issues New Legislation To Ban Human Organ Trade
4. Africa: Traditional Knowledge of Medicine Needs To Be Protected With Due Legislation
5. Legislation to Prevent Discrimination against HIV/AIDS Victims
6. Smartcard Legislation Fails The Privacy Test - AMA
7. AMA Urges Government To Amend Aged Care Legislation
8. US Lawmakers Considering Legislation to Restrict Payments by Drug Companies to Doctors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... ... Center for Autism and Related Disorders (CARD) Portland today announced plans to host ... other developmental disabilities. The group, which is being launched with the help of Robbie ... share stories and advice, seek help, and continue their education on how to best ...
(Date:12/2/2016)... ... December 02, 2016 , ... Dr. Raffi Hovsepian, a leading ... the 2016 “Guide to America’s Top Plastic Surgeons” for seven consecutive years. The ... education, experience, and professional associations. , One the most frequently honored surgeons ...
(Date:12/2/2016)... Cleveland, OH (PRWEB) , ... December 02, 2016 ... ... provider of veterinarian diagnostic imaging systems and the first company to ... Robot With a Heart at their tradeshow booth # 941 for the American ...
(Date:12/2/2016)... ... 02, 2016 , ... Clarify Health Solutions, Inc., the leading ... in an initial round of funding. The round was led by experienced investors ... receive far better care through the application of the best technologies from other ...
(Date:11/30/2016)... (PRWEB) , ... November 30, 2016 , ... ... to announce that we have been designated as a Cigna Infertility Center of ... exceed rigorous performance standards. , “It’s an honor to be designated a ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... - bioLytical lanza el INSTI HIV Self Test para el mercado ... Continue Reading ... New: INSTI Self Test! ... , bioLytical Laboratories (la "Compañía"), un líder mundial ... lanzamiento de su INSTI HIV Self Test  a África con una versión de ...
(Date:12/2/2016)... According to the latest market report published by ... Reprocessors: Single Basin Automated Endoscope Reprocessors Product Type Segment Anticipated ... the global automated endoscope reprocessors market was valued at US$ 740.6 Mn ... of 7.2% during an eight-year forecast period 2016-2024, to reach ... ...
(Date:12/2/2016)... , Dec. 2, 2016 In the ... sources apart from those derived from C. sativa, the ... Universita` di Napoli Federico II , the Universita` ... the first comprehensive, critical, integrated and unified inventory of ... article focuses on the remarkable chemical and structural ...
Breaking Medicine Technology: