FDA drug approval processes and clinical trial phases

Biotech Regulation

Regulation in Biotechnology

FDA

The Food and Drug Administration has been in existence since 1902

Even prior to the biotechnology age, the FDA had regulatory power over drugs and certain medical devices

In the mid 1980s, major reforms of FDA powers and responsibilities were instituted

The Coordinated Framework for Regulation of Biotechnology (1986)

Legislation and policy reform that led to greater coordination between federal agencies

Established clearer criteria for biotechnological advances and products

FDA works within similar parameters to the USDA and the EPA, ensuring the quality and safety -- both personally and to the environment -- of biotechnological developments

Time and Costs Associated with Regulation

The FDA's drug approval process is slow and arduous, requiring large amounts of capital from producing companies

Information from independent clinical trials is often utilized by the FDA in the decision making process, leading to some concerns regarding bias and reliability

A lack of adequate funding and a still-present reluctance to rely on outside expertise continue to hamper the FDA's regulatory efforts and slow the approval process

Phase 1 Controversies

Recent studies have found that Phase 1 trial results are far less likely to be published than other medical research findings, including the results of later trial studies

Manufacturers argue that confidentiality is essential in the industry, and that the need to protect proprietary information is of greater importance than making early findings public

Critics suggest that there is failure in ethical duty when the dangers and risks of a new drug are not made available to physicians or the public in the form of publication

Phase 2 Trials

Phase 2 trials consist of larger groups of people being administered the drug; safety of the drug is still a major concern during Phase 2 trials

Determining the efficacy of the drug in combating specific diseases and/or symptoms is the primary research goal during a Phase 2 trial

Phase 2 participants generally have some symptomology of the disease/condition the drug is attempting to address, in order to determine efficacy

Phase 2 Controversies

Until recently, subjects in Phase 2 trials (and in clinical trials generally) did not have to be registered

This allowed companies to conduct testing at greatly reduced costs in the developing world, with populations that were often not fully informed of the risks

Registration was mandated by legislation in 2007, closing this loophole and creating more human rights accountability in the industry -- as well as raising costs

Quality Assurance in Biotechnology

Clinical trial phases are meant in large part to ensure the quality of pharmaceutical products

The FDA also has other regulation in place to maintain ongoing quality and consistency of the pharmaceuticals available on the market

Quality assurance in other areas of biotechnology is also a matter of federal policy and legislation

Generic Drugs

The FDA mandates that all generic drugs must have the same formulary as brand name drugs, and that the brand name product be used as a reference for many points of manufacture

Dosage forms and delivery methods of the drug must be the same as available through brand name suppliers

The same standards of raw material usage and ingredient proportions must also be adhered to Genetic Engineering

Still at the controversial forefront of the biotechnology industry, genetic engineering is increasingly regulated at the federal level

Primary concerns are the health of individuals and the effects on the environment of genetically engineered plant species and bacteria

Oversight has not kept pace wih technological advances, though this gap has narrowed significantly in recent years

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