Tuesday, February 25, 2020

Tuesday, February 25, 2020

Pharmacology professor, expert speaks out on FDA drug safety

David Gortler, a professor of pharmacology and a former FDA official, says the FDA needs to do more to ensure the quality of drugs delivered to the U.S. market, with particular concern given to generic drugs produced in “sweatshop” countries.

Gortler, who worked as a policy adviser to Ted Cruz during the 2016 presidential campaign and who has testified in front of the Senate on numerous occasions, was asked by the FDA Reporter about the FDA drug approval process and other issues affecting the organization.

“Well, the FDA does a pretty god job of reviewing and assessing drugs for safety and efficacy in clinical trials, but they should be doing more to assess and control drugs once they reach the market,” Gortler told the FDA Reporter.

“The real-world application of drugs versus tightly-controlled environment found clinical trials are titanically different. Mandating safety reporting to the FARES database is one thing the FDA could do. The FDA also needs to start taking a good, hard prospective look at the generic drugs coming in from ‘sweatshop’-type countries overseas including India, China, Taiwan and the Middle East.”

According to his biography on the Heartland Institute website, Gortler also works as the chief medical officer of Valisure.

That organization is a Yale startup medical device company, which analyzes and validates the labeled purity of overseas “sweatshop” generic drugs.

“The FDA relies on generic drugs quality control measurements done by the generic companies themselves. As it is now, there is nearly zero third-party, or FDA- quality control testing of generic drugs taking places of these drugs coming in from overseas drugs, and it frankly negligent and unacceptable,” Gortler said.

Gortler has had professorships at three top medical schools including Yale, George Washington and Georgetown, according to his biography. He also has authored or coauthored more than 50 publications and papers regarding the pharmacology subject.

Gortler also is on the editorial board of several different peer-reviewed medical journals and serves as the editor-in-chief of Advances in Investigational Pharmacology and Therapeutic Medicine.

GortLer said the FDA has not done a good job in regard to the storage of its drugs.

“All prescription drugs that do not require refrigeration or freezing, are mandated to be stored at room temperature (68-77F) or they risk becoming denatured and/or impure,” Gortler said.

The biggest problem are the mail order houses in Arizona where temperatures sometimes hits 110 degrees and higher. And in delivery trucks or mail boxes, it can get even higher.

Gortler said that Express Scripts, Walgreens, Caremark and Humana all use mail order houses in Arizona.

“The FDA entrusted the Arizona board of pharmacy to regulate the storage of its drugs, and the board has failed to fulfill its obligations. The Arizona State Board of Pharmacy and Arizona's Attorney General on the pharmacy board turn a blind eye to these obvious violations in order to maintain state tax income from these large mail-order houses,” Gortler said.

“On top of these drugs being denatured by excessive temperatures, these mail order houses dispense only the cheapest drugs from the aforementioned ‘sweatshop’-type countries, making them double questionable with regard to integrity and quality.”

Organizations in this Story

Heartland Institute

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FDA Reporter