October 25, 2009
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Allergan sued the FDA earlier this month, claiming that the FDA’s prohibition of off-label promotion violates Allergan’s First Amendment rights by preventing Allergan from communicating about BOTOX’s REMS restrictions to physicians who need the information to properly treat off-label. As the Allergan press release says:
“To serve the objectives of the FDA-mandated REMS program for BOTOX(R) and to assist physicians in evaluating the benefits and risks of the product, Allergan seeks a judgment that would permit it to provide currently available and truthful information to doctors for common off-label uses of BOTOX(R)”
I.e., the REMS forces Allergan to discuss the off-label uses. Hrm. The In Vivo Blog picks this one up and runs with it:
“the simple truth is that FDA now has the authority to do exactly what Allergan wants—allow, or indeed, require greater communication about off label uses. The suit focuses on the fact that FDA is not allowing as complete communication as Allergan wants—but the fact is that FDA could allow that under the existing law and in some sense “approve” an off-label promotion campaign.”
We’ll keep an eye out for the decision, but we don’t expect the District Court’s word to be final. Meanwhile, having a product subjected to REMS ”restrictions” is looking better and better.
October 19, 2009
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Over at The In Vivo Blog, Michael McCaughan has another thought-provoking piece on REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs.
Michael compares two drugs for the same indication — opioid-induced constipation therapy, if you must know — and though they have similar mechanisms of action and were both developed by small biotechs and picked up by big pharmas, they met different ends (har).
Wyeth gave Progenics back the rights to Relistor last week, paying $10 million to do so; but GSK is continuing to market Adolor’s Entereg.
The difference? According to Michael, Wyeth was facing big marketing commitments, but GSK was not. Here’s the rub: GSK’s marketing commitments were limited because Entereg is marketed under a REMS that limits its use to an “ultra-restrictive indication.”
So, we now have two situations where REMS confer an unexpected benefit:
- Limiting marketing expenditures for a marginally successful partnered drug (the partnered part is key — without that, marketing budgets can be adjusted at-will, without regard to minimums); and
- As previously noted by Michael and discussed here, limiting generic competition for off-patent drugs (REMS don’t die or fade away, they just complicate life for generics).
In each case, I’d leave it to the math guys to calculate whether the benefits outweigh the costs of the sales limitations that come with a REMS (not to mention the direct compliance costs); but if your partnered product isn’t looking like a blockbuster or is closer than you’d like to patent expiration, maybe it’s a good time to look over the FDA’s recent draft REMS guidance — a “useful blueprint for how to develop these important safety strategies.”
July 2, 2009
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Some suggestions for things to do:
And some suggestions for things not to do:
June 27, 2009
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A great post from Michael McCaughan at the In Vivo Blog walks through the very complicated interaction between the world of REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs — and the world of generics.
Under the FDA Amendments Act, which started the whole REMS business, REMS programs aren’t supposed to block or delay generic competition; but it’s not clear the legislators thought this through. Says Michael:
does FDA really want to make it simple for dozens of sponsors to launch versions of drugs like thalidomide, when the agency has already determined that the risks of inappropriate use are high enough to merit costly, burdensome post-marketing restrictions?
We’ll find out soon… The generics maker Dr. Reddy’s has been unable to obtain any of Celgene’s anti-cancer drug Revlimid to use as a comparator in bioequivalence trials, so they’ve filed a citizen petition with the FDA. Dr. Reddy’s is proposing mandated access to REMS-covered drugs at market prices for FDA-authorized generics manufacturers.
His bottom line:
Our hunch: products covered by restricted distribution programs will end up looking more like biotech therapies facing follow-on competition than they will like conventional generic drugs.
My bottom line:
If that hunch is right, we’ll know soon enough because innovator pharmas will all be planning REMS generics to go along with their biosimilar plays.