FDA’s dilemma over Avastin

FDA was expected to announce a decision on September 17,2010 about whether Roche’s (Genentech, US) top-selling cancer drug Avastin ($6 billion global sales last year) would remain on the U.S. market for the indication of advanced breast cancer.  Instead, FDA announced 3 months of additional review time to look at newly submitted clinical information by Genentech. Details of this new information has not yet been publicized.

In July 2010, FDA’s Oncologic Drugs Advisory Committee voted 12:1 for removal of “advanced breast cancer” as an indication from Avastin’s label after reviewing clinical data of two large studies conducted by Genentech (Read more: http://www.medpagetoday.com/HematologyOncology/BreastCancer/21218). The ODCA made its decision after data from the newer studies clearly failed to confirm the magnitude of progression-free survival seen in an earlier study (which was the study on which the drug was granted Accelerated Approval status in the first place).

But, ODAC is not the only party putting pressure on FDA. Lately, patients have started petition drives asking FDA to not remove the indication. These late-stage breast cancer patients claim that the drug appears to be working for them and taking the indication off the label would result in “off-label” use of the drug and would not be covered by their insurance. Certain members of Congress have also sent protest letters to the FDA (Read more: http://www.fiercepharma.com/story/breast-cancer-patients-press-fda-keep-avastin/2010-09-16).

FDA now has the tough job of weighing the concerns of all parties and making the best decision for the health of the American public. Genentech, who generates billions of dollars from sales for breast cancer treatments, cancer experts & patient advocates, who believe the drug should be removed given its high toxicity and cost factor, and cancer specialists & late-stage breast cancer patients,who believe that this treatment is better than no treatment at all–will be anxiously waiting December 17,2010–the new deadline by which FDA will announce a decision.

Are overstated marketing claims higher on FDA’s radar?

While it is not uncommon for pharmaceutical companies to overstate the efficacy of their products and downplay serious side effects, FDA is now taking a strong stance; stronger than just issuing warning letters — a possibility of “stern FDA regulatory action, including seizure or injunction, without further notice.”

This strict warning was recently given to Baxter International, Inc. for its lung drug Aralast because FDA says that Baxter is claiming efficacy levels that are not true, despite having received 2 warning letters regarding this issue already. Now, FDA wants Baxter to not only remove those claims but also to come up with a plan to make sure all its drug promos tell the truth.

While this may not have been pleasant news for Baxter folks, who have very recently had to deal with heparin (imported from China) issues and a Hylenex recall, this is definitely good news for patients and physicians who have had to deal with unforeseen complications that arise out of falsely marketed claims.

It seems that FDA has become more vigilant of drug-marketing materials over the years, as evident by the issuance of 68 warning letters so far this year, which is nearly twice more than 2009 (41) and more than three times greater than 2008 (21).

To read the letter, click here:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224225.htm

Is FDA starting to crack down on post-marketing commitments? What does this means for the industry?

FDA proposes to remove Shire Low Blood Pressure drug from the market

Shire’s low blood pressure drug, ProAmatine, along with its 5 generic forms (by: Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories) are being considered for withdrawal by the FDA after the companies failed to show any follow-up data, despite receiving a request for 2 follow-up studies from FDA last year. ProAmatine was approved in 1996 under the accelerated approval process which grants early approval for drugs that show efficacy for serious, life-threatening conditions but also requires companies to follow up with post-marketing data to prove how the drug works.

Interestingly, Shire responded by stating that the follow-up studies they conducted were considered inconclusive by FDA and that the company notified FDA about withdrawing their NDA for ProAmatine, citing low revenues from the drug, back in November 2009. Read more here: Shire’s response to FDA’s proposal to withdraw ProAmatine

It will be interesting to see, in the days that follow, if FDA will continue cracking down on post-marketing commitments and how pharmaceutical companies will react to FDA’s actions.

The Drug Development World According to Pfizer’s Global Head of Policy

Had a delightful dinner last night with Greg Simon, Global Head of Policy at Pfizer. Some meaningful thoughts he had. I’m summarizing, and mostly quoting a snippet that had meaning for me.

Greg: I was on the (Obama’s) FDA transition team, we interviewed people who have worked with FDA since 80s, we were in a windowless room, for 2 days in a row, talking to FDA. More than 1 person burst into tears. People have been there 10, 20, 30 years, no one has ever asked their opinion.  They are overwhelmed, underfunded, constantly criticised. They now have dynamic leadership, with the smartest people out there. The thing that I see that is challenging is now they (FDA leadership) aren’t asking the industry to do anything. I think it behooves the FDA to constantly ask the people from industry “What are you doing to make this better”. The budget at FDA is going up, but it has a lot farther to go. Currently 60% of the FDA budget is paid by the industry. This has to change, and PhARMA is trying to play a huge role in getting it there.

We are trying to put some game changers on the table with FDA, not about deadlines, but about attitude: attitude about safety, attitude about risk taking, attitude about what it means to introduce a drug into society. You can’t have a war against cancer without some casualties and patients are willing to take those chances, but FDA won’t let them. How do we convince people that it’s a game we all share, it’s not a game you play against somebody. Patients, doctors, drug companies, everybody have to be involved in sharing the risk, sharing the data, total transparency so they understand what works and what doesn’t.

We must put patients first in everything we do. We have to bring it up all the time. Patients are partners in everything we do, whether you’re a VC, pharma company, regulatory.  Urge us all to think, “how would it look if you’re in a hospital bed”. We have a lot more to do, a lot more to say. I urge you to do it with patients in mind. Don’t be shy with getting patients involved in this. If we delegate this to trade associations and government lobbyist, we all lose.

Welcome!

Halloran Consulting Group has a mission:

• To teach, lead, and empower our clients with practical solutions and expert advice on efficient and effective use of resources to successfully manage and accelerate the development of life-improving and life-saving therapies.
• To design, develop and implement appropriate infrastructure that optimizes our clients’ development processes while maintaining compliance with regulatory and quality practices.
• To promote innovation in the business of life science through thought leadership on best practices and virtual product development.

We are committed to transforming the process by which drugs, biologics, medical devices, and diagnostics are developed and brought to patients.

See “About Us” for more details and THANK YOU for following our weblog.