In a bid to open a window into the way it does business, the FDA has released a Transparency Report containing 21 draft proposals for public disclosure policies. This is all part of the three-phase Transparency Initiative that was launched last year. The proposals cover such areas as adverse event reports; the docket management process; enforcement priorities and actions; import procedures; inspections; product applications; product rejections; recalls and warning letters. All in all, this is more info that drugmakers are used to seeing disclosed.
At the end of the day, the FDA hopes this process will better explain agency decisions, provide more data to doctors and patients, "illuminate" enforcement efforts and support innovation for rare diseases. How so? If the FDA explains an abandoned application for an orphan drug could represent a significant therapeutic advance, this could prompt another company to continue with the application. "By implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products," FDA deputy commish Josh Sharfstein and agency attorney Afia Asamoah write in an essay in The New England Journal of Medicine.
There is a lot to chew on in this 67-page report. And so the FDA is seeking public comment on the proposals, "including input on whether we have struck the right balance between disclosure and confidentiality in support of public health. Because FDA cannot implement all of the proposals at once, we are asking for input on how to prioritize," Sharfstein writes in the report. The agency will be taking public comments until July 20.
5 Comments
Where to start?
If a big pharma company uses another facility for QC testing and/or manufacturing steps, and this "other facility" does the same for a handfull of companies, logic follows is to EXTENSIVELY AUDIT the middleman. Common sense plays a role in that statement.
Accuracy of compliant or noncompliant items, with considerable focus on electronic records should be looked at first because the "health" of their Quality Units will be pretty evident by raking a fine toothed comb in the validity of their records.
Materials used in products that come from somewhere in the US as well as oversees needs almost the same amount of more-than-just-enough scrutiny.
The FDA should consider doing a better job. There is a lot of s&$t out there, and it's beginning to drift towards their way.
MB
mr sharfstein seems to have forgotten that the foia is bemoaned by industry for obvious reasons.
Mr sharfstein.. get another job.
The FDA is always producing reports complete with important proposals. -They actually need to start doing something.
I'm late to this party -- but here is how the FDA proposal would help us all -- quite immensely:
It all started last week, at New Merck's R&D Day webcast, and continued at the Banc of America conference presentation made by Merck, a few days later, last Thursday.
Tonight Matt Herper, for Forbes, ably notes, if the FDA's increased disclosures initiative makes its way into the rule book intact, we will no longer be left to wonder what -- exactly -- is the holdup at FDA on putatively new drugs, like a Zetia® (ezetimibe) plus Lipitor® (atorvastatin) combo. Here's the Forbes piece -- but do go read all of Matt's:
". . . .Making the [FDA's] letters public will prevent companies from misleading investors about what went wrong, he wrote, but it will also prevent rumors that things are worst than they are. . . .
For instance, at Merck's recent analyst meeting some Wall Streeters wonder whether an FDA delay in approving a combination of Merck's Zetia and the soon-to-be-generic Lipitor reflects concerns on the FDA's part about Zetia. Merck says it comes down to manufacturing issues. In the future, there may not be any argument to have. . . ."
Let us all hope so.
For the record, I think such a pill isn't much of a meaningfully "new drug", at all -- and while Lipitor is a wonderful drug, there is little evidence to suggest that Zetia is doing anything to improve clinical outcomes. So, it would be reasonable to infer that FDA is taking a "wait and see" approach, until the results from IMPROVE-IT become known (that is Zocor® plus Zetia®, in the Merck-marketed combo pill called Vytorin®) -- as it is also a statin (simvastatin), plus ezetimibe. Could well be. And that could be 2014, or even beyond.
Namaste
With regard to the proposal to make public the FDA complete response (CR) letters: The objective is reasonable but publishing the CR might be an 'over the top' way to do it. Some people in industry think that a limited disclosure solution would be a better way to go. A significant number of products which receive a CR go on to be approved after additional info has been submitted by the sponsor. The CR provides too much inside info to other companies, who are often trying to develop similar products, (mainly because of the limited options available to them in a highly competitive global *marketspace*) Perhaps FDA could issue press releases which contain enough info to inhibit companies from putting too much spin on the contents of the actual CR. Other companies with similar products in development will receive advice from FDA anyway, based on accumulated FDA experience of reviewing similar types of products, but without mentioning specific products of course.