FDA Law

According To Goldwater, The Fda Must Determine That Potential Benefits Justify The Potential Risks Of A Drug, And That Such Risks Are Not Unreasonable Given The Disease.  Furthermore, The Fda Must Determine That A Patient Has A Life-threatening Disease, That Drug Access Won't Interfere With A Clinical Study Or Development Of The Drug, And That The Patient Can't Otherwise Obtain The Drug.  Goldwater contends That It Has Not Received Enough Records To Determine Whether The Fda Met its Own Criteria In The Ebola Case.

FDA Attorney

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District Judge Susan Bolton to order the release of more records. "The drug approval process in the United States shouldn't be a government secret," said Jonathan Riches, a Goldwater Institute attorney. "The public has a right to know how drugs are made available to the patient." FDA attorneys argued that the agency considers information about yet-to-be-approved drugs to be confidential and proprietary to the companies seeking FDA approval to market their drugs.  The FDA corresponds with every drugmaker on various topics — for example, a drug's purity, toxicity and pharmacology — as part of its deliberative process, said  agency attorney Leslie Cohen.   "That is why the deliberations are inextricably intertwined with confidential, commercial information," Cohen said. In 2014, Goldwater filed a Freedom of Information Act request for records about the FDA's approval process, deliberations and final approval records that allowed an experimental drug to be used on Brantly and Writebol. The FDA denied Goldwater's initial records request in 2014, citing an exemption under a provision that protected trade secrets and confidential commercial information.  In its federal lawsuit, Goldwater argues that it did not seek commercial trade secrets or private patient information. It wants to "determine whether the government followed its own requirements when it made a life-saving drug available to patients infected with the Ebola virus," according to a Goldwater motion for summary judgment. The court already ordered that the FDA produce an index that identifies records that have been withheld and the reason the federal agency did not produce those records.  When the federal agency produced the index of records, Goldwater contended that exemptions claimed by the FDA did not apply and some records classified as non-responsive may have been responsive to Goldwater's request. According to Goldwater, the FDA must determine that potential benefits justify the potential risks of a drug, and that such risks are not unreasonable given the disease.  Furthermore, the FDA must determine that a patient has a life-threatening disease, that drug access won't interfere with a clinical study or development of the drug, and that the patient can't otherwise obtain the drug.  Goldwater contends that it has not received enough records to determine whether the FDA met its own criteria in the Ebola case. Goldwater is familiar with the FDA's emergency drug-approval process. The watchdog group has championed “right-to-try” bills and voter initiatives in Arizona and several other states.

For the original version including any supplementary images or video, visit https://www.azcentral.com/story/money/business/health/2017/10/10/goldwater-lawsuit-phoenix-fda-ebola-drug-zmapp-approvals/748238001/

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