What is USFDA Approval?

The Food and Drug Administration (USFDA or FDA) is a federal agency in the United States which is a regulatory body that is responsible for ensuring the safety of food and drugs. FDA claims responsible for protecting public health and ensuring the safety, the security of human and veterinary drugs, products and medical devices. FDA is also responsible for regulating the manufacturing, marketing, and distribution of tobacco and in making medical products more effective and safer for public use.

What are some of the things that the FDA regulate?

The FDA evaluates the safety and efficacy of
• Prescription drugs for humans and animals
• Over the counter drugs
• Biologics
• Dietary supplements
• Medical devices
• Surgical implants
• Food Additives
• Cosmetics
• Products that give off radiation
• Tobacco products
• Infant formula

 

What does it mean when a product is ‘FDA approved’?

An FDA approved product means that the agency has determined the ‘benefits of the products outweigh the known risks for the intended use’ Manufacturers submit a premarket approval application (PMA) to the results of the clinical testing to the FDA to get an approval.
FDA does not ‘approve healthcare facilities, labs, and manufacturers and does not develop or test products before approving them. To approve a product, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers.

The FDA approval process

 

On average it takes about 12 years and 350 million USD to get a new drug to a pharmacy shelf. Once a company develops a new drug it undergoes several lab testing (approx. three years) before an application is made to the USFA to begin the drug testing in humans.
Only one in 1000 compounds that enter laboratory testing will make it to human testing. Once, the FDA gives the go signal the drug will then enter three phases of clinical trials. After these the company then submits an application (about 1,00,000 pages) to the FDA for approval, this whole process can take up to two and a half years. At the final approval, the drug becomes available for prescription. It has been found out that research-based pharmaceutical industries currently invest 12.6 billion USD a year in the development of a new drug.

A new MIT study has found that nearly 14 percent of the drugs that are involved in clinical trials eventually win approval from the FDA. According to the FDA, currently, there are over 19,000 prescription drug products approved for marketing, 6,000 different medical device product categories, 1,600 FDA approved animal drug products, and 240 FDA-licensed biologics products.

 

The FDA outlines five phases in the development of a new drug into the market, they are:
• Phase 1: Discovery and Development
• Phase 2: Preclinical Research
• Phase 3: Clinical Research
• Phase 4: FDA review
• Phase 5: PFDA Post-Safety Marketing

 

How can I know if my medicines are FDA approved?

One can know the ins and outs of almost every drug approved by the FDA since the year 1939 by using the Drugs@FDA database which is available on their website. You can search for information about FDA-approved brand name and generic drugs and therapeutic biological products.

The Drugs@FDA database includes most of the drug products approved since 1939 and has information available such as drug labels, patient administration, approval letters and other information available for most approved drugs since 1998.

Are all the FDA approved drugs perfectly safe?

The answer is no. No drug product is entirely or ‘’perfectly’ safe. Every single drug that affects the body will have some side effects. For a product to be FDA approved it means that ‘the benefits outweigh the risk of the product’. FDA makes sure the labelling of the product outlines the benefits and the risks reported in the tested population. You and your physician should decide whether if the benefits outweigh the risks for you.

Some of the facts about the FDA are

• The FDA is responsible for the oversight of more than $2.6 trillion in the consumption of food, medical products, and tobacco.
• FDA regulated products account for about 20 cents of every dollar spent by US consumers
• It regulates about 77 percent of the US food supply
• Has over 20,000 prescription drugs approved for marketing
• Oversees 6,500 medical device product category
• Has over 1,600 FDA approved animal drug products
• 400 FDA-licensed biologics products
• Oversees 85,000 tobacco products
• Their regulations cover about 35,000 produce farms, 3,00,000 restaurant chain establishments and 10,500 vending machines operated
• FDA products are manufactured or handled at nearly 2,70,000 registered facilities and over half of them are located overseas.
• 80 percent of active pharmaceutical ingredients are located outside the United States
• FDA regulated products account for 13 percent of US imports and 19 percent of US exports,
• About 70 percent of the biologics sales of FDA approved products are imports
• About 53 percent of fresh fruit, 29 percent of vegetables and 93 percent of seafood consumption by volume are imports
• About 35 percent of medical devices used in the US are imports
• About 4 percent of animal products and 3 percent of tobacco product sales are imports,
In the end, the Food and Drug Administration agency that works for the safety of public health. Their mission is to be responsible for the advancement of public health by helping to speed up innovations that make medical products more effective, safer and more affordable and by helping the public get the accurate, science-based information they need to use the medical products and foods to maintain and improve their health

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.