Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’

Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration (FDA) has the responsibility to govern the process by which pharmaceutical companies introduce new products and seek approval. Two methods generally are followed.

The first – traditional approval – involves a process that proves the drug has a defined clinical benefit. Does it inhibit the effects of diabetes? Does it lower blood pressure or cholesterol? Does it reduce mental anxiety? Does it support heart health? Answers to such questions are gathered by preclinical testing on animals followed by three rounds of clinical testing on humans, all before the FDA will consider the application by the medical manufacturer.

“Clinical trials are studies that use human subjects (people) to see whether a drug is effective and what side effects it may cause,” according to Living Safer Magazine. “The trials are for gathering information about a drug that has not yet been proven to treat patients with a specific condition.”

The research into so-called investigational drugs determines qualitative and quantitative facts, including physical benefits, side effects and contraindications with beverages, foods or other medications, in addition to dosages, frequency and how long the active ingredients stay in the body.

“When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits a new drug application (NDA) to the agency,” the article reads. “The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics and statistics.”

If the FDA approves the application, the company is allowed to market, sell and promote its product – often a multimillion-dollar venture.

The second method for approval is accelerated approval. Accelerated approval is reserved for drugs that relate to serious conditions and life-threatening illnesses without cures. The process cuts the time it takes for a drug to become available.

An example of a drug that received accelerated approval is Gleevec, which aids patients with chronic myeloid leukemia, a rare form of cancer, by blocking enzymes. Instead of the proposed pill going through the four-phase, traditional-approval process, it went through a process based on a surrogate endpoint. A surrogate endpoint is a marker that measures health benefits less directly than a clinical trial but is a best practice used in emergency situations.

“Under accelerated approval rules, if studies don’t confirm the initial results, the FDA can withdraw the approval,” the magazine explains. “Because premarket review can’t catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program.