The U.S Food and Drug Administration (FDA) is entrusted with the responsibility of evaluating and approving medicines for varied medical conditions. The FDA Center for Drug Evaluation and Research (CDER) acts as a regulatory watchdog for all pharmaceutical companies. After extensive research and testing, pharmaceutical companies need to approve medicines from the CDER, before launching it in the market.

Specialized teams of scientists, doctors, pharmacologists, and chemists thoroughly review the research findings before approving any drug. An extremely critical procedure, it may take as long as 10 years for a single drug to make it through the stringent checks and reach potential customers. The FDA’s drug approval practices vary from one drug to the other. Mostly, drugs are approved on a case-by-case basis. As a result, the same standard may not be followed for approving all drugs. At times, the FDA can make exceptions to its own guidelines and approve one drug while rejecting another.

 

 

Aiming to Create Transparent Approvals

While the FDA takes great pains to pass medicines which they deem fit, the process can be quite frustrating for researchers and pharmaceutical companies. In order to resolve this issue, a team of three researchers from UCLA Anderson devised a method to ensure transparency in the FDA’s approval techniques. The researchers, Taylor Corcoran, Fernanda Bravo, and Elisa Long created a quantitative framework for evaluating issues which are considered qualitatively by the FDA.

The study takes into consideration certain factors such as the availability of alternative treatment and the severity of the disease. The group focuses on 14 disease-specific factors which are known to affect the approval process. Based on the conditions that need treatment, the model has set different efficacy targets for each drug. According to the researchers, customized significance targets will help to bring about better transparency in the FDA’s drug approval process.

Customized Drug Approvals

Depending on the medical conditions a drug treats, the FDA customizes its drug approval process. Certain disease-related factors may ease the approval for some drugs. But, other drugs may be subjected to tougher standards. The new study by UCLA Anderson researchers aims to include all these factors into the FDA’s drug approval procedure.

In order to make the approvals lenient for high-severity and high-prevalence diseases, the researchers suggest a quantifiable and transparent process. According to them, the recommended significance level must be in accordance with the underlying condition that a drug is supposed to treat.

Risk Factors

Although transparency is desirable, risk factors cannot be ignored. The FDA is responsible for approving drugs and medical devices that are efficient as well as safe for patients. But, efficacy is not a risk-free procedure. The failure of drugs to treat medical conditions prolong suffering and it is highly unintended for patients. Therefore, the agency tries to approve only those drugs which carry an acceptable risk of failure and may not harm or prolong the patient’s pain.

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