How The FDA Stifles New Life-Saving Drugs

Did you know that our government is the major roadblock to the discovery and production of new critical life-saving drugs? At every turn we are seeing how Washington rules and regulations prevent Americans from moving forward and no area is more onerous than in the field of medicine. Read this excellent article by Dr. Paul Hsieh.

America has a serious drug problem, but it’s not one most Americans have heard of. The problem is not illegal drugs, but rather a critical shortage of many life-saving legal drugs. And the federal government is about to make things worse.

During the past year, medical professionals have received alarming reports about critical shortages of important drugs. These drugs aren’t the common over-the-counter medications that consumers purchase in their local drugstores. Rather, the shortages are in various injectable drugs typically administered to seriously ill patients in hospitals.

Melly Alazraki of Daily Finance reports that the shortages include “vital medications such as chemotherapy, antibiotics, analgesics (painkillers), anesthetics and more.” ABC News details how Minnesota cancer patient Mark McKee was suddenly told at a scheduled chemotherapy session that the hospital did not have enough of the critical medication doxorubicin for his prescribed treatment. Despite the fact that his tumor had grown recently, his doctors told him he had to settle for a significantly reduced dose and hope that “something may be better than nothing.”

Of course, various factors can contribute to the shortage of any specific drug — for instance, a manufacturing problem at a key factory or difficulty obtaining a particular raw material from an unstable foreign country. But as ABC News notes, often the problem is simply that “the production cost outweighs the profits.” And a leading cause of this problem is the federal government, specifically in the form of the Food and Drug Administration (FDA).

FDA regulations impose an enormous financial burden on drug companies. In a detailed critique of the FDA, pharmaceutical industry writer Stella Daily Zawistowski observes that the FDA drug approval process currently costs companies approximately $800 million “from the time a molecule is discovered in the laboratory through animal trials and multiple stages of trials with human subjects.” Furthermore, the 20-year patent clock starts “ticking” once the drug is discovered, even though the drug approval process often takes more than 10 years. Hence, a company that spent enormous sums developing a new drug might enjoy less than half of that theoretical 20-year patent life to recover its initial investment before other companies start selling chemically identical cheaper “generic” versions.

In addition to stifling the development of new drugs, Zawistowski emphasizes that the FDA also distorts the market for the types of drugs being developed. It’s generally faster and cheaper for pharmaceutical companies to get FDA approval for “copycat” drugs that are minor variations of already-approved medications than to get approval for groundbreaking new drug categories. Hence, we see a plethora of cholesterol drugs, sleep aids, and antidepressants — and fewer advances in other vital categories, such as antibiotics effective against drug-resistant bacteria. In fact, UCLA medical school professor Dr. Brad Spellberg has warned that our pipeline of these vitally needed new medications is nearly empty because the FDA is “a huge impediment to getting a new antibiotic to market.”

The FDA drug approval process is so onerous that many experts believe that certain drugs currently in widespread use would never have been approved by today’s FDA — including penicillin, aspirin, and acetaminophen (Tylenol). In 2010, the FDA approved a mere 21 drugs — what the Wall Street Journalcalls “a relatively modest figure” and a continuation of the “drought in recent years.”

The Obama administration has acknowledged that the slow pace of new drug development is a problem. However, their response is not to reduce government barriers to private drug development — but rather to create a new government agency to supposedly “fix” this problem. According to the New York Times, the Obama administration will create a “National Center for Advancing Translational Sciences” within the National Institutes of Health (NIH) to “help” promote new drug development. But many scientific and industry experts are deeply skeptical that this new program will succeed. (read more at Pajamas Media)