NCPA - National Center for Policy Analysis

FDA Testing Needs Reform

January 13, 2015

Potentially life-saving drugs spend years undergoing FDA review, limiting ill patients' ability to access what might be miracle treatments. In a new report, Lindsay Boyd of the Beacon Center of Tennessee explains what FDA regulation has done to drug access.

The Food and Drug Administration (FDA) was created in 1938. While the agency could require drug safety testing before drugs could get on the market, it wasn't until 1962 that its power over the drug market became even more significant. That year, new federal laws required FDA drug testing for efficacy, and the agency -- and expenses -- exploded in size. According to Boyd:

  • In 1951, there were just 1,000 staffers working for the FDA. Twenty years later, the agency had 6,500 employees.
  • It now costs from $500 million to a whopping $2 billion to get a drug to market.
  • There is less drug development today than there was in 1962.
  • Since 1970, patients have had to wait more than 10 years for new, and potentially life-saving, drugs.

According to Boyd, 40 percent of the increase in American life expectancy is owed to the development of new drugs from 1986 to 2000. However, more could be done: the FDA approval process is incredibly slow, requiring several stages of review:

  • Phase I of FDA approval consists of safety trials, costing an average of $15.2 million and generally taking 22 months.
  • Phase II evaluates safety and dosage, costing companies $23.4 million and taking an average of 26 months.
  • Phase III involves drug testing on a larger group of individuals to gather more data on safety and efficacy. Not only does it cost a staggering $86.5 million on average and take 30 months, but it can still take up to two years before the drug is available to patients.

With FDA approval being so lengthy, can sick patients participate in clinical trials? According to Boyd, the vast majority (97 percent) of the sickest patients are ineligible for clinical trials. They can, however, petition the agency for "compassionate use," allowing them access to drugs that have yet to receive FDA approval. Unfortunately, the process is cumbersome:

  • Compassionate use requires approval from the drug developer and the patient's doctor, and the FDA must decide the drug is safe enough for experimentation and that experimentation will not interfere with ongoing trials.
  • Applying for compassionate use requires 100 hours of paperwork from the doctors sponsoring the patients.

Boyd encourages Tennessee to adopt a "right-to-try" law, which would allow terminally ill patients to access drugs that have completed Phase I testing. So far, five states (Colorado, Louisiana, Michigan, Missouri and Arizona) have passed these laws.

Source: Lindsay Boyd, "The Pursuit of Hope: Tennesseans' Right to Try Potentially Life-Saving Medicines," Beacon Center of Tennessee, December 2014.  

 

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