Vladislav Gurin :: BioTech & Pharma consulting

Hundreds of federal, state, and local regulatory agencies define the legal regulatory environment for pharmaceuticals, agricultural and medical biotech. For example, in the pharmaceutical industry, the key agencies that define the business parameters include the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), as listed in table below:

The FDA, which is part of the U.S. Department of Health and Human Services (HHS), is responsible for promoting and protecting the public health by helping safe and effective products reach the market in a timely way, and by monitoring products for continued safety after they are in use.Its reach extends from food, drugs, and medical devices to biologics, animal feed and drugs, cosmetics, and radiation-emitting products. In the realm of pharmaceuticals, the FDA regulates the drug development process to ensure patient safety. FDA oversight includes preclinical safety assessment, preapproval safety assessment in humans, safety assessment during regulatory review, and post marketing safety surveillance.The goal of preclinical safety assessment is to identify drugs that are effective against a targeted disease in animals without causing significant toxicity. Preapproval safety assessment in humans involves a lengthy clinical trial process culminating in the preparation of a New Drug Application (NDA) seeking FDA approval for manufacturing, distributing, and marketing a drug in the U.S. During the approval process, pharma companies must supply the FDA with any additional safety information that it obtains. Post marketing safety surveillance, also known as Phase IV trials, may be required by the FDA or conducted voluntarily by the pharma company, depending on the frequency and severity of reactions noted in the clinical trials. Post marketing surveillance is highly regulated by the FDA. For example, pharma companies must inform the FDA of reports of serious, unexpected adverse drug reactions anywhere in the world within 15 days.Pharma firms that fail to follow the drug development process as outlined by the FDA aren’t allowed to market their products in the United States. Furthermore, even if drugs are thoroughly evaluated for efficacy and side effects, the FDA has the power to remove drugs from the U.S. market if significant side effects are reported in patients taking the drugs.Some of the major legislative initiatives implemented by the FDA that profoundly affect the pharmaceutical industry include the Orphan Drug Act, the Prescription Drug Marketing Act, the FDA Modernization Act, and the Health Insurance Portability and Accountability Act. The Orphan Drug Act is designed to encourage the development of drugs to serve markets of fewer than 200,000 patients. It provides a seven-year period of market exclusivity and a 50 percent tax credit for clinical research expenses involved in developing the drug. The Prescription Drug Marketing Act was enacted in 1988 to limit the diversion of prescription drugs into a secondary gray market. Another major piece of legislation affecting the pharmaceutical industry is the FDA Modernization Act of 1997, which streamlined many of the processes used by the FDA, and reduced and simplified many regulatory obligations of pharmaceutical manufacturers.The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the Department of Health and Human Services (HHS) in part to ensure the privacy of patients who take part in clinical trials. HIPAA requires pharmaceutical companies to follow stringent security practices to prevent patient data from being accessed by those without access privileges.In addition to the Food and Drug Administration, the U.S. Patent and Trademark Office (USPTO) is a major constituent of the legal-regulatory infrastructure of the pharmaceutical industry. The USPTO establishes the limits of the temporary monopoly granted pharmaceutical companies by virtue of drug patents and other intellectual property protection.

August 9, 2007 at 2:28 pm | Business news
- Posted by Editor-in-Chief | Add Your Comments

Please, read related posts in my blog: