Free Speech 0611
This article was originally published in RPM Report
Prescribing Data Gets Day in Court
The U.S. Supreme Court heard oral arguments over the constitutionality of Vermont's restrictions on the use of physician prescribing data by pharmaceutical companies for marketing purposes. The majority of justices appeared likely to strike down the statute.
"You want to lower your health care costs, not by direct regulation, but by restricting the flow of information to the doctors, by, to use a pejorative word, censoring what they can hear...so they will do what you want them to do when it comes to prescribing drugs."
Supreme Court Chief Justice
John Roberts Jr.
Sorrell v. IMS Health Inc. oral arguments, April 26
"Why doesn't that run up against what this Court has said that you can't...lower the decibel of one speaker so that another speaker—in this case the generics—can be heard?"
Justice Ruth Bader Ginsberg
Sorrell v. IMS Health Inc. oral arguments, April 26
"The way the First Amendment works in the marketplace of ideas that so upsets Vermont is that both sides get to tell their story....The thing that is supposed to be biased here is that the drug companies have too much money. That is not a basis for restricting speech."
Thomas Goldstein
IMS Health counsel (Goldstein, Howe & Russell)
Sorrell v. IMS Health Inc. oral arguments, April 26
"Drug companies would certainly like this information for marketing, but they have no First Amendment right to demand it, just as they have no right to demand access to a doctor's tax returns, his patient files, or to their competitors' business records."
Bridget Asay
Vermont Assistant Attorney General
Sorrell v. IMS Health Inc. oral arguments, April 26
Lipitor Uncertainty Continues
Mylan's attempt to force a decision by FDA on the status of Ranbaxy's "first-to-file" generic version of atorvastatin was dismissed in court. Will Ranbaxy be able to launch or won't they?
"[Mylan] may fervently wish for the FDA to act on Ranbaxy's ANDA; such desires, however, do not equate with standing….Not only are Plaintiff's alleged harms speculative, but they are so generalized as to be applicable to almost any competitive business situation."
DC federal court Judge James Boasberg
May 2 ruling dismissing Mylan suit against FDA
"This was an industry issue. This is not a Mylan and an FDA issue. And I do believe that the FDA is constrained. As I've said before, I believe ultimately, that they will come to the right place….I even think that the judicial system was empathetic about exactly what our issue is. However, I think that they ruled specifically on the standing issue using from a pure legal perspective and I even think that the opinion stated that had we have the standing, there should be a little bit different of an issue. So I think we've struck the right balance. We're going to continue to work with the FDA and continue to represent the industry and pushing for a result that can be supported by the fundamental facts."
Robert Coury
CEO, Mylan Inc.
Quarterly earnings call, May 3
"In response to the demand received from the DOJ of USA, [Ranbaxy] is negotiating on the matter and in this context has given a settlement offer towards resolution of all outstanding matters. This offer is expressly conditional on the successful negotiation of several administrative actions by the US FDA also. At present there is significant uncertainty about the outcome of the above-mentioned matters and therefore no provision has been made in these Unaudited Standalone Financial Results."
Ranbaxy Inc.
Quarterly earnings report, May 10
REMS Reconsidered
FDA's new Risk Evaluation & Mitigation Strategy authority puts the agency much closer to regulating the practice of medicine—and that is a challenge for everyone involved.
"REMS is a result of the health care system not being able to keep people safe. So we have to build on top of it, build into it additional fail safe steps…REMS has to be integrated into the workflow of healthcare….We aren't trying to break anything that is fixed."
Janet Woodcock
Director, Center for Drug Evaluation
Food & Drug Law Institute annual meeting, April 5
"The health care providers are struggling to figure how to implement what we have put on them, both from FDA and the sponsors."
William Fitzsimmons
SVP, Astellas Pharma US
Food & Drug Law Institute annual meeting, April 5
"The problem is not intrinsically the drug company or the drug…It is the providers…Yeah, FDA doesn't regulate providers. Neither does anyone else much. That is the problem."
Nancy Buc
Former partner, Buc & Beardsley
Food & Drug Law Institute annual meeting, April 5
Reimbursement and Business Development
FDA approval is no longer the endgame in drug development; reimbursement is. How is that affecting biopharmaceutical deal making? A panel of experts discussed that topic during a recent Elsevier Business Intelligence webinar. For a replay or transcript of the April 19 webinar, "How Payer Pressure Influences Dealmaking and How You Can Prepare," visit our website: www.elsevierbi.com/webinars.
"You have that dichotomy between fulfilling the regulatory need,and then addressing what comes after that, which is obviously the reimbursement environment and the data that payers would like to see in order to make reimbursement and also formulary decisions. And I think the emphasis that we have today, still on the premarket environment, is going to shift slowly over the next 3 years more towards the post-market environment."
Felix Frueh
President, Medco Research Institute
"The reimbursement world has changed so radically, only within the last two years, where you see actual pressures impacting as significantly as they have the uptake of particular products. So, I would have suggested that launches in 2006 and 2007, particularly in the United States, weren't nearly as affected by payers as launches in certainly 2009 and 2010 have been….So to some extent, the challenge to the pharmaceutical industry is that they really have no track record of being able to predict the reimbursement environment, simply because the reimbursement environment has changed so radically from what they formerly understood."
Roger Longman
CEO, Real Endpoints LLC
"Payer pressure is becoming increasingly a driving factor in the deals that we do. It is not a sole factor by any means, but it is a becoming more influential in the type of the deals we evaluate and the deals that we will go through that. Our senior executives have given us kind of a mantra that we now look at payer reimbursement and what it would take for that. It just not good enough now to have an approvable product, but we also need to have a reimbursable product at the same time."
John Gustofson
Director of Strategic Partnering and Business Development, AstraZeneca
"We are really seeing a substantial shift in the curve of interest, where we have relatively robust proof of concept – meaning shifting in terms of disinterest. And the thoughts are basically did we use the right comparator? Should we have been using a real-life comparator rather than placebo, which has been kind of the low-risk? And we are actually starting to see these pressures upon us, and the need to actually utilize head-to-head competitors and maybe in subpopulations relatively early. I think the change is now."
Eric Rowinsky
Independent Consultant,
Board Member of Biogen