Senator Johnson Wants to Weaken the FDA – We Asked Why

June 12, 2018

This article is part of a series on right-to-try and the FDA. Please click here to read the first article in the series.

Unfortunately we haven't heard back from him. After the Senator, sponsor of the Senate version of the right-to-try legislation wrote, “This law intends to diminish the FDA’s power over people’s lives, not increase it,” in a letter to the FDA Commissioner, we wanted to know more about his views on the legislation and the FDA in general. We sent his press contact a similar set of questions to the ones answered by Christina Sandefur, of the Goldwater Institute. So far we have had no response.

We can probably get a good idea about where Senator Johnson stands from his discussions about the law he sponsored. The Senator recently discussed the law with conservative talk show host Vicki McKenna

In the interview, the Senator says that the law “... restores a little bit of freedom and gives terminally ill patients a little bit of hope.” As noted by many critics of the law, the FDA is rarely the reason that patients are not able to receive experimental treatments. Usually the manufacturers deny patients access to treatments in development. Ms McKenna notes this as well but also makes the claim that the FDA's application for compassionate use requires over 100 hours to complete.

This 100 hours reference appears to have been true for the previous compassionate use form. However the form was dramatically streamlined in 2016. The form is now  two pages and is supposed to take less than one hour to complete. Both the NYU Medical School and the Regulatory Affairs Professional Societyprovide information confirming the dramatic reduction in the time it takes to complete the form. It is possible that Ms McKenna and the Senator are not aware of the changes to the form.

In support of the idea that the FDA compassionate use program is too difficult for patients and doctors to navigate, Senator Johnson points out that in France (at approximately 1/5 the population of the US), 12,000 people access experimental drugs, while in the US only about 1200 people use the compassionate use program. This is not an valid comparison.

The comparison is inaccurate in a number of ways. For one, the 1200 number in the US represents applications – not people in the program. Applications can be for one or for many patients. Of the 1,256 compassionate use permissions granted by the FDA in the year 2014-2015, 62 were for more than one patient. 54 were deemed intermediate, meaning more than one but less than “many.”  Eight were deemed large. A large compassionate use program could include more than 1000 patients. No one knows the actual number of patients who access experimental drugs in the US via the compassionate use program, but it is more than the number of granted approvals.

Another way the comparison between the US and France's programs is not valid is that in France, the government pays for the experimental medications. Experimental drugs are rarely paid for by insurance in the US, and the cost can be in the tens of thousands or more.

Additionally, the French program is not similar to the US right-to-try law. In France, government agencies are heavily involved in overseeing the use of experimental drugs.

One statement by Senator Johnson seems to indicate that he harbors significant distrust (possibly even dislike) of the FDA and its motives, “My main concern with manufacturers not participating is that the FDA still is in charge of the approval process and they can apply an awful lot of pressure.” So the Senator is suggesting that the FDA may retaliate against companies that provide access to experimental treatments outside of clinical trials. This is in contradiction to a number of statements from drug companies about why they frequently deny experimental treatments to patients. Usually the reasons given include cost to the companies (some treatments are developed by small cash-strapped companies), limited supply (often only enough of the drug is made for trial participants), potential delay in trial completion (patients not screened for trials may be more likely to experience adverse events that could put the trial on hold), etc.

The Senator's statement that the FDA still (italics ours) is in charge of the approval process raises the question of if he intends to change the FDA's role in the approval process as well.

Later in the interview, Senator Johnson mentions the letter he is writing to the FDA Commissioner and says, “Let me be clear, Vicki, the intent of this piece of legislation was not to increase the FDA's power over our lives, but actually to diminish it...” He goes on to say that he will be, “bird-dogging the FDA,” to make sure the FDA's guidelines related to the law empower the patient.

Major donors to Senator Johnson's campaigns have similar views on the FDA as he does. The top donor in the 2016 campaign cycle was Club for Growth. The Club for Growth was by far the largest donor making a contribution almost seven times the next leading donor. The Club for Growth is staunchly in favor of reducing the size of government and has worked closely with Americans For Prosperity. Charles Koch until very recently was the chairman of the Americans for Prosperity Foundation. Koch Industries was the 6th largest campaign contributor to Senator Johnson's 2016 campaign. Johnson has been described as the Koch's model legislator in an article by Ken Vogel on Politico.

Charles Koch apparently believes that the FDA stands in the way of innovation. In a free ranging discussion with the Washington Post's Jim Tankersley, that covered many topics,  Koch said, “...if you just allow innovation and have the FDA not make it almost impossible to develop a new drug, that costs a fortune and cost create this huge structure of pricing.”  The Koch Brothers have also supported a number of groups advocating the right-to-try legislation.

While it is only possible to make an educated guess at Senator Johnson's ultimate plans for curtailing the FDA's power, given his statements and the views of his major supporters, it seems to be a pretty safe bet that he favors additional reductions in the agency's oversight of drug development and marketing. Hopefully we will hear from him directly so that we can gain a more complete picture of how he believes the FDA could be re-shaped to better serve the public.

image courtesy of Gage Skidmore on Flickr



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