On September 27, 2007, President of the United States

President of the United States

The President of the United States of America is the head of state and head of government of the United States. The president leads the executive branch of the federal government and is the commander-in-chief of the United States Armed Forces....

 George W. Bush

George W. Bush

George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....

 signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) into law. This new law is an important step for the Food and Drug Administration (FDA). It reviewed, expanded, and reaffirmed several existing pieces of legislation

Legislation

Legislation is law which has been promulgated by a legislature or other governing body, or the process of making it...

 regulating the FDA. These changes will allow the FDA access to much-needed resources that will enable the agency to better protect American consumers by allowing more comprehensive reviews of potential new drugs and devices.

Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) (IV) was first enacted in 1992 to allow the FDA to collect “user fees” from biotechnology and pharmaceutical companies. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007. The purpose of these fees is to provide resources to the FDA that help them more effectively review potential new drugs. The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety

Pharmacovigilance

Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...

 program, allocate more resources for television advertising

Television advertisement

A television advertisement or television commercial, often just commercial, advert, ad, or ad-film – is a span of television programming produced and paid for by an organization that conveys a message, typically one intended to market a product...

, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers.

Medical Device User Fee and Modernization Act (MDUFMA)

• Allows for user fees
  User fees
  People pay user fees for the use of many public services and facilities. At the federal level in the US, there is a charge for walking to the top of the Statue of Liberty, to drive into many National parks, and to use particular services of the Library of Congress.States may charge tolls for...
  
   which will allow the FDA to make significant improvements in the medical device
  Medical device
  A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
  
   review program.
• Establishment inspections may be conducted by accredited persons (third-parties), and establish new regulatory requirements for reprocessed single-use devices. FDAAA changes the medical device establishment registration requirements, although both foreign and domestic drug manufacturers still must register establishments.

Best Pharmaceuticals for Children Act (BPCA)

• Encourages more studies in children and promotes the development of treatments for children.
• Intended to improve FDA and applicant accountability for the agreed-upon pediatric studies.
• FDAAA broadens the definition of “pediatric studies” to include preclinical studies, and narrows the timeframe for sponsors to qualify for pediatric exclusivity.

Pediatric Research Equity Act (PREA)

• Continues FDA's authority to require studies in children concerning certain medical products and under other specific circumstances.

Priority review to encourage treatments for tropical diseases

• The priority review voucher
  Priority Review Voucher
  The priority review voucher is a prize awarded in the United States to the developer of a treatment for neglected diseases. The prize was proposed by Duke University faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 Health Affairs paper: "Developing Drugs for Developing...
  
   rewards the developer of a treatment for a neglected disease
  Neglected Diseases
  The neglected diseases are a group of tropical infections which are especially endemic in low-income populations in developing regions of Africa, Asia, and the Americas. Different organizations define the set of diseases differently...
  
   with a transferable right to priority review for another treatment at the FDA.

Reagan-Udall foundation

• To modernize product development
  New product development
  In business and engineering, new product development is the term used to describe the complete process of bringing a new product to market. A product is a set of benefits offered for exchange and can be tangible or intangible...
  
  , accelerate innovation, and enhance product food safety
  Foodborne illness
  Foodborne illness is any illness resulting from the consumption of contaminated food, pathogenic bacteria, viruses, or parasites that contaminate food, as well as chemical or natural toxins such as poisonous mushrooms.-Causes:Foodborne illness usually arises from improper handling, preparation, or...
  
   with clinical trial
  Clinical trial
  Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
  
   registries provisions by an advisory committee intended to enhance drug safety.
• Also created to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

Advisory committee conflicts of interest

• Continues the requirement that all individuals under consideration for appointment to serve on an FDA advisory committee disclose to the Agency all financial interests that would be affected by the committee’s actions.

Clinical trials reporting

The FDAAA also requires registration and reporting of basic results of clinical trials of medicines and devices subject to FDA regulation on the freely-accessible site ClinicalTrials.gov

ClinicalTrials.gov

ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 93,000 trials from more than 170 countries in the...

.

External links

• http://www.fda.gov/oc/initiatives/advance/fdaaa.html
• http://www.fda.gov/oc/initiatives/HR3580.pdf