How does FDA approve GD?

The introduction of a generic drug leads to switch prescriptions from branded drugs to cheaper generic alternatives. The FDA structure where the people who approve the drugs when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them.

The FDA organizational structure is currently geared towards the review and approval of new drugs. When a serious safety issue or any problem arises at post marketing, the immediate reaction is almost always one of denial, rejection and heat. They approve the drugs, so there can’t possibly be anything wrong with it.

Prescription Drug User Fee Act(1992):

The Prescription Drug User Fee Act came into 1992, is a way of providing the FDA with more funds so that it can hire more physicians and other scientists to review drug applications so that drugs would be approved more quickly considering the safety issue.

The breakthrough drugs – the ones that really make a difference in patients’ lives and represent a revolution in pharmacology – are following the strict criteria and guidelines to meet the safety of the drug.

There are two things that the FDA determines when it looks and review at a drug: it determines whether or not a drug is safe and it determines whether or not it’s effective.

Determination of safety and effectiveness of Drug:

The first job of FDA is the determination of drug effectiveness and patient’s safety. According to Dr. David Graham – A senior drug safety researcher at the FDA, American public can’t be very confident on the safety side of a drug. They can have some confidence because it turns out that most drugs are remarkably safe. But, when there are unsafe drugs, the FDA is very likely to err on the side of industry.

In Case of Unsafe Drugs:

In case of unsafe drug, FDA keeps a drug from being marketed or pulls a drug off the market as FDA follows so many criteria and standards to maintain drug’s safety. The standard that the FDA uses to approve a drug is primarily “does the drug work?” That’s what they call efficacy. The FDA conducts test for the drug companies to prove that a drug only has to be better than a sugar pill. The assumption is that the drug will be no different than the sugar pill.

The way the FDA’s approval standards are, the drug does not necessarily have to have a very great effect in order to be approved. The primary concern is whether or not the drug is safe.

Finally FDA is that it overvalues the benefits of drugs and undervalues the risks of drugs.