Jun 03 2010

FDA Ups the Ante on Transparency

Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one.

– Helmut Jahn

I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s most recent move on the subject really takes the cake.  If you are in any way involved in drug, biologic, or device development, stop what you’re doing and read this.

What is it?  The FDA’s Transparency Task Force released a report that outlines 21 draft proposals for changing FDA disclosure policies.

These include, but are by no means limited to, having the FDA disclose and/or confirm the existence of INDs, the indications being investigated, and the name of the product.

But, it’s not just information within INDs that could be offered up to the masses.  The proposal would also have the FDA disclose the name of the sponsor, receipt date, indications, and product name for all applications (NDA, NADA, ANDA, ANADA, BLA, PMA, and 510(k)).

So, in effect, everyone would know what everyone else is working on.  Forget “regulatory intelligence” as we know it.  Anyone who can use a search command will instantly know what their competition is.  Would you approach your pre-IND meeting differently if you knew there were zero active applications for the indication rather than, say, 20?

Also, imagine the effect on patent/exclusivity litigation!  To quote the Drug and Device Law:

“If you think the pioneer/generic wars are bad now, imagine how they’ll be when everyone knows exactly what applications are pending for what.”

If those weren’t enough to make you think, one proposal would allow the FDA to release raw (non-summary) safety and efficacy data from applications under certain circumstances (e.g., if it would provide a public health benefit).

Of course, these are only draft proposals.  Some, most, or all will not enter the realm of reality without modification, if even then.  Several would require changes to law, regulation, or both.  Many would require significant resources to implement.  Still, even proposing some of them has made the earth move under the feet of the industry.

Think these proposals are worth commenting on?  You have until 20 July 2010 to submit comments www.regulations.gov or www.fda.gov/transparency.

Allow me to close with the quote on the first page of the Transparency Task Force report:

“[G]overnmental decisions, particularly regulatory decisions, should be based on publicly available information. . . . This premise underlies the Freedom of Information Act, the Federal Advisory Committee Act, and the Government in the Sunshine Act. In enacting each of these statutes, the Congress implemented a basic principle of our political system: that people affected by governmental decisions have a right to know the basis on which they are made. Anyone who questions the wisdom of a regulatory decision should be able to examine the factual foundation of the decision.”

– FDA Commissioner Donald Kennedy, 1978