FDA Transparency
http://www.minyanville.com/businessmarkets/articles/fda-fda-new-guidance-drug-approval/5/20/2010/id/28410
Ever since new management took over at the FDA, the agency has been on a mission to become more accessible to the American public. While this hasn’t yet had a dramatic effect on how the drug-approval process is conducted or how the public interacts with the agency, it now has the potential to be a major game-changer for investors.
The FDA announced Wednesday that its Transparency Task Force has come up with 21 proposals that could finally make the FDA more readily available to the average person. If you've ever been on the agency’s website, you know that its current iteration is far from user-friendly.
The proposals, based on user feedback after two public meetings, are meant to help consumers and others better understand the process the FDA takes when making decisions. The agency and the task force will be accepting public comment on the proposals and will decide in late July which of them are going to stick.
The task force’s ideas address the lack of usability on the FDA website, as well as corral information from other regulatory websites that might relate to drug products (like US Justice Dept. cases), and most importantly would make public disclosures related to drug approval, rejection, and evaluation.
That last part is incredibly important and could have pharmaceutical and biotech companies scrambling to find a way to keep this from happening. The new proposals would allow the FDA to disclose the contents of Complete Response Letters -- a practice that could devastate a company stock price. Complete Response Letters are issued by the FDA to a company when a drug is rejected. In those letters the agency tells the company why a drug wasn't approved and what steps, if any, can be taken to reach approval. This is currently a private matter between the agency and the company; it's at the company’s discretion to release the letter -- something that's virtually unheard of.
The proposals extend further to the disclosure of when the FDA has put a hold on a clinical trial, when a drug development application is withdrawn by the sponsor, whether it agrees with published reports about products with approvals pending, and why it does not approve a marketing application. This transparency would also extend to disclosure of when the FDA inspects a plant – including what plant and what sort of violations were found.
http://www.minyanville.com/businessmarkets/articles/fda-fda-new-guidance-drug-approval/5/20/2010/id/28410
Ever since new management took over at the FDA, the agency has been on a mission to become more accessible to the American public. While this hasn’t yet had a dramatic effect on how the drug-approval process is conducted or how the public interacts with the agency, it now has the potential to be a major game-changer for investors.
The FDA announced Wednesday that its Transparency Task Force has come up with 21 proposals that could finally make the FDA more readily available to the average person. If you've ever been on the agency’s website, you know that its current iteration is far from user-friendly.
The proposals, based on user feedback after two public meetings, are meant to help consumers and others better understand the process the FDA takes when making decisions. The agency and the task force will be accepting public comment on the proposals and will decide in late July which of them are going to stick.
The task force’s ideas address the lack of usability on the FDA website, as well as corral information from other regulatory websites that might relate to drug products (like US Justice Dept. cases), and most importantly would make public disclosures related to drug approval, rejection, and evaluation.
That last part is incredibly important and could have pharmaceutical and biotech companies scrambling to find a way to keep this from happening. The new proposals would allow the FDA to disclose the contents of Complete Response Letters -- a practice that could devastate a company stock price. Complete Response Letters are issued by the FDA to a company when a drug is rejected. In those letters the agency tells the company why a drug wasn't approved and what steps, if any, can be taken to reach approval. This is currently a private matter between the agency and the company; it's at the company’s discretion to release the letter -- something that's virtually unheard of.
The proposals extend further to the disclosure of when the FDA has put a hold on a clinical trial, when a drug development application is withdrawn by the sponsor, whether it agrees with published reports about products with approvals pending, and why it does not approve a marketing application. This transparency would also extend to disclosure of when the FDA inspects a plant – including what plant and what sort of violations were found.
