Integrity of FDA and Big Pharma Questioned by Former FDA Commissioner; Dr. Herbert Ley

Over the years, debates have sparked about the potential regulation of the vaping industry out of the existence involving the collaboration of Big Pharma and the government of the United States. However, what we ought to find out is whether this stories can be proved to be true or are just mere conspiracy theories.

Most Americans believe that the United States Food and Drug Administration (FDA) is fully funded by the federal government. This is in fact false and the truth is far more unethical.

To illustrate this, many vapers might be amazed to discover that Pharmaceutical companies have been paying millions of dollars to the FDA, in annual fees since the 1990s. The approval times on new medications would take a ridiculously long time, and when companies started complaining about the lengthy durations. The government of the United States took this matter into its own hands and literally suggested that the companies should pay to have the approval times shortened.

Instantaneously, the very drug companies that the FDA had federal authority to regulate and police, started partially funding the FDA. This became the perfect example of putting somebody in charge of a job when they clearly have conflict of interest. The ultimate definition of a bad idea.

Dr. Herbert Ley’s Famous Quote

Dr. Herbert Ley, the former FDA commissioner, handed in his resignation after running the FDA for a period of three years, in the late 1960s. He was immediately summoned for an interview by the San Francisco Chronicle where he explained the reason he had quit his job with the following quote.

“The FDA protects the big drug companies and is subsequently rewarded, and using the government’s police powers, they attack those who threaten the big drug companies. People think that the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks it is doing are different as day and night.”

This interview took place close to 70 years back and by the look of things, the situation doesn’t seem to have changed. Anne Wilde- Mathews, a reporter who shared similar views to the former FDA commissioner disapproving the FDA, went a few steps further and stated the following in a Wall Street Journal article dated 2006.

“Regulators usually do not negotiate their budgets with the industries they oversee… For most of its history, the FDA was funded entirely by Congress. But in the early 1990’s companies unhappy with the pace of drug approvals agreed to pay the FDA millions of dollars in annual fees to help speed its performance. Because the industry and the agency renegotiate every five years over the size of fees – and what they can be used for – drug makers can have considerable input, into which programs receive funding.”

“Each time the arrangement has been renewed, the FDA has gained new funding. In return, industry has wrung concessions. In the 1997 deal, the review time for a standard application  dropped from 12 months to 10 months. In 2002, the FDA agreed to a number of changes, including a new deadline for how fast the agency would respond to companies’ requests for meetings about their drug applications.”

Now this is where the problem comes in, the government of the United States can apparently not see the conflict of interest arising from the close relationship between Big Pharma and the FDA. And when FDA scientists with good intentions try to correct the nationwide conversation surrounding the controversial issue of vaping by attempting to publish scientific research that may be supportive, they are usually told to remain silent about the subject and sometimes the repercussions can even be worse. Many a time, they are directed to alter their scientific conclusions or stand a chance of losing their jobs if the instructions are not followed. For the vaping industry, only time will tell whether things will improve. Who knows what the future may hold ?