The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: FDAAA

Dreaming of REMS: A Second Reason Why FDAAA Risk Evaluation and Mitigation Strategies Might Be a Benefit to Drug Developers

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:

  1. 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
  2. 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.”

Bookmark and Share

REMS and Generics — Like Oil and Water

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.

Bookmark and Share

Disclosure, Disclosure, Disclosure

Disclosure issues have permeated the news lately.  Pharmaceutical companies need to do a better job of disclosing adverse clinical trial results and side effects; companies and doctors need to do a better job of disclosing payments; and journals need to do a better job of disclosing author conflicts.

You could view the question of whether to disclose from a lot of different perspectives, but I’m hard pressed to find one that argues in favor of secrecy: economic (efficient markets), legal (Exchange Act, FDAAA, FTC), and corporate (reputational harm) considerations all seem to point to disclosure.

While there will always be some level of outright fraud, and there is risk to individuals who do disclose (risk to future work, inability to publish, etc.), institutions should be moving toward increased disclosure. 

Some have:

  • GlaxoSmithKline is heading in the right direction.  Last year they promised to publish payments to U.S. doctors for consulting and other services starting in 2010, and to cap those payments at $150,000 per doctor a year. Now, the company is planning to expand its disclosure to include money paid to doctors and their institutions to carry out clinical trials, and fees it pays European doctors for advice on developing new drugs.
  • The American Psychiatric Association (pdf) Board of Trustees voted this month to phase out industry-supported symposia along with industry-supplied meals at its annual meetings.

I vote for more.

Bookmark and Share

Follow

Get every new post delivered to your Inbox.

Join 126 other followers