FDA fast-tracking unproven drugs to public

Although the Food and Drug Administration's Accelerated Approval Program was created in 1992 to speed up the approval of new drugs, new research reveals a large number of drug manufacturers are failing to complete the approval process, according to a report in the American Association for the Advancement of Science (AAAS).


What this means is that a significant number of drugs on the market are not yet fully approved — a sobering thought.

The FDA’s function is supposed to be stopping harmful drugs from reaching the public, but a much-used revolving door exists between the FDA and the pharmaceutical industry, which is putting Americans' health at jeopardy for the sake of the drug industry's greed.

More than a few FDA workers look for a future position with drug industries because it translates to dramatically increased salaries. In an analysis of 55 former FDA medical reviewers, 15 subsequently took jobs with the biopharmaceutical industry, which strongly suggests that FDA reviewers considering future work in the drug industry might be more lenient when stamping “approval” on new drugs.

FDA drug approval rates continue to increase every year. The FDA granted 45 new drug approvals in 2015, which was the most approvals granted in one year since 1996.

The end result is that FDA-approved drugs may appear to be more beneficial than they really are. And, once FDA-approved, these drugs must be covered by Medicare and Medicaid programs, and the agencies are unable to negotiate prices.

Speaking of cozy business relationships between government and industry, nothing quite matches the one that Congress has encouraged federal health agencies to create with the drug and vaccine industry.

Here’s how it works: The FDA Amendments Act of 2007 allows companies developing treatment for rare pediatric diseases to pay the FDA for a priority review vouchers to fast-track approval of the drug or vaccine, typically securing fast-track approval in six rather than 10 months. Those same drug companies can then legally sell their vouchers to other companies, including vaccine manufacturers, for millions of dollars to fast-track licensure of completely different, profitable drugs and vaccines, such as the HPV vaccine.

While medical fraud is not new, recent information exposed the unconscionable actions of drug manufacturer Novartis after the company manipulated experimental data prior to FDA approval of the most expensive treatment on the market. The deceit cost a patient $2.1 million for treatment of a rare muscle-wasting disease affecting approximately 400 children each year.

In other cases, before clinical trials revealed a deadly list of side effects — including heart attacks and deaths — drugs such as Vioxx have been put on the market and advertised to consumers.

Sure, many drugs are vital to treating diseases, but it’s also OK to be skeptical and do some research with any prescriptions that are recommended for your health. Be aware and wary when drug companies promote drugs as the answer to better health and wellness. Don’t forget that your life choices have a significant effect on your health, including nutrition, sleep, hydration and exercise.