FDA responds to criticism of Alzheimer's drug review process by refusing to pre-declaration and claim...

The FDA has long worked collaboratively with drugmakers to bring new drugs to market for approved applications.
but when a drug is controversial, the relationship between regulators and businesses is vulnerable to blame.
In December, Public Citizen, a consumer advocacy group, issued a scathing letter of criticism about the FDA's review process for Biogen's controversial Aducanumab listing, saying that Billy Dunn, director of the Office of Neuroscience, and other reviewers had "inappropriately worked closely" with the company and "dangerously undermined" the independence and objectivity of the review.
Public Citizen recommends that a "firewall" be established among FDA staff to prevent similar situations from happening again in the future.
the organization wrote in an open letter to the FDA: "... We understand that it is not uncommon for the FDA to meet with bidders and advise on the development of drugs and biological products, the design of clinical trials, and statistical analysis of trial data.
As these interactions may be transferred to cooperation with the bide, potentially undermining the integrity of the FDA review (as happened in the review of aducanumab), the FDA should designate other staff members who are not involved in such interactions prior to NDA or BLA filing to review and make decisions regarding any subsequent DAs and BAs for these drugs or biological products.
to ensure the integrity of these reviews and decisions, firewalls should be created between FDA staff involved in pre-reporting interactions and those involved in post-report NDA or BLA reviews and decisions.
" but Janet Woodcock, acting director of the FDA, rejected the recommendation in a February 11 letter to Public Citizen, "your proposed firewall would significantly reduce the efficiency of the FDA review process and lead to delays in drug development."
firewall is not required to ensure the integrity of FDA decisions.
" Public Citizen's letter at the time not only recommended the need for a firewall, but also requested the Department of Health to conduct a full investigation into the aducanumab review process, including a careful review of Dunn's relationship with Yan Jian's executives, and asked Stephen Hahn, then FDA Director, to temporarily remove Dunn and the relevant reviewers until the review is complete.
woodcock did not respond to questions about the firewall in his response letter.
She said the delays caused by such firewalls could seriously hamper the development process and prevent patients from getting timely access to the drug: "The FDA's interactions with applicants not only help ensure that preclinical and clinical development programs are properly designed to generate the data needed to support applications, but also reduce the likelihood of duplicate or other unnecessary testing in humans and animals."
to make FDA clear about its expectations, participants in the review must have a thorough understanding of development plans from the preclinical to the clinical stage.
, head of the Public Citizen Health Research Group, said Woodcock's letter was "full of caution."
said Woodcock "fully supports the FDA's interactions with pharmaceutical companies during the drug development process."
praised the benefits of these interactions and ignored their possible drawbacks, especially in the FDA's review of aducanumab at an FDA expert meeting last November.
"he continued: "It is not surprising that she rejected our offer.
since the Prescription Drug User Payment Act (PDUFA) was first enacted in early 1990, the FDA has developed an increasingly close relationship with pharmaceutical companies.
" it all began last November, when a panel of experts reviewing aducanumab voted almost unanimously to reject the drug's approval, sharply criticizing FDA reviewers who rated the drug highly and questioning the agency's ethics.
Aducanumab has long been one of the most controversial drugs in the pharmaceutical industry, and Yan Jian insists that the drug will be the first treatment to reduce cognitive decline in Alzheimer's patients, but the company's data processing methods, including a review brief co-authored with the FDA, have unnerved many scientists and outside observers.
PDUFA deadline for the drug has been extended from March 7 to June 7.
But concerns about possible damage to the independence and objectivity of the review between experts who provide scientific advice to drug developers before filing and reviewers who later apply for review do not only occur at the FDA, but have also been investigated and improvements implemented within the EU.
European Watchdog launched an investigation in July 2017, focusing on whether the European Medicines Agency's (EMA) final decision on a listing permit application was influenced by scientific communication about the design and conduct of clinical trials before filing.
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