free speech-1207
This article was originally published in RPM Report
Executive Summary
Government and industry experts discuss the rise of risk management programs, e-Prescribing, progress on follow-on biologics and the cautiousness of FDA.
FREE SPEECH
How Many REMS?
FDA says it won’t use its new risk evaluation and mitigation strategy authority excessively. One ex-FDAer wonders whether the agency can stick too that.
"We need to maintain active understanding of the safety profile of all the drugs that are out there on the market. That is our job. But we don’t need to order REMS on all of them. That would be a disaster."
Janet Woodcock
Chief Medical Officer, FDA
Food & Drug Law Institute conference November 16
"I am not a lawyer, but I am an implementer."
Janet Woodcock
Chief Medical Officer, FDA
"I am waiting for the first hearing on Capitol Hill on risk management programs where the congressman tells FDA: ‘We gave you the authority; why didn’t you use it.’ Or for the first hearing where Congress demands: ‘Did you do the auditing of the risk management program?’"
Scott Gottlieb, MD
American Enterprise Institute, former FDA deputy commissioner; "Transforming Health" conference, Nov. 16, sponsored by PhRMA and Research America
E-prod for E-prescribing
Pharmacy benefit management companies are putting on a full-court press for Medicare to force more e-prescribing and the Medicare agency issued proposed standards for Part D on November 14. But it is the public statements by some big political figures that has e-proponents hoping for a big push from Congress.
"Most doctors haven’t invested in the necessary technology to do e-prescribing. The reasons are complex and range from a perceived lack of financial incentives to a reluctance to give up the familiar prescription pad. It is not expensive. This change needs to happen and, from my standpoint, sooner rather than later."
Michael Leavitt
Secretary, Department of Health & Human Services
November 20 posting on HHS Secretary’s blog
"The federal government can lead by requiring that doctors who do business with Medicare convert to e-prescribing. This can be done by using market forces and the federal government’s purchasing power to align financial incentives…. This is something Republicans and Democrats can agree on. While we continue to debate how to cover the uninsured, improve quality, and lower costs, there is too little being done to modernize health care."
John Kerry and Newt Gingrich
Editorial published in The Wall Street Journal, November 16
Calculating Regulatory Risk
Increased regulatory hurdles and a prolonged approval drought are common themes in when investors assess the current climate for pharma. Is it going to get tougher or easier for pharma to get new products?
"Very early stage investors focus on trying to model risk…The one risk that they cannot model, that they cannot get any appreciation for, is regulatory risk. It is a very black-box risk. There is no computational model they can build."
Scott Gottlieb, MD
American Enterprise Institute, former FDA deputy commissioner
"Transforming Health" conference, sponsored by PhRMA and Research America, November 16
"Drug safety is something we are going to have to respond to. To pretend that that wouldn’t affect in some way how the agency reacts to the public would be disingenuous. On the other hand, we are a rules-based agency. We respond to the rule of law, what Congress tells us to do. I do not see a change within the agency to wake up, get out of bed in the morning, and all of the sudden decide to up the ante on the amount of data that are required for medical approval."
Douglas Throckmorton, MD
Deputy director, Center for Drug Evaluation & Research
"Transforming Health" conference, sponsored by PhRMA and Research America, November 16
The Path to a Follow-On Pathway
Congress is still working on follow-on biologics legislation in hopes of moving a bill in 2008. It sure sounds like industry and FDA are ready.
"We are moving into a world where these molecules are going to be out there….We just want to make sure that it is going to be traceable back to who got what product, so that if and when there are problems that they don’t get laid on to a class of products."
William Bennett
Senior director, science & policy assessment, Genentech Inc.
Food & Drug Law Institute conference, November 15
"There are a lot of things that we don’t know, but there are also a lot of examples we hear of where the tools we do have told us something was different, even if they didn’t necessarily tell us why….There is always uncertainty in agency decisions."
Steven Kozlowski
Director, Office of Biotechnology Products, FDA
FDLI conference, November 15
"What a difference a year can make."
Jake Hansen
VP-government affairs, Barr Laboratories Inc.
"We are going from infinite to finite in terms of exclusivity, so this is like culture shock here."
Kay Holcombe
VP-government affairs, Genzyme Corp.
FDLI conference, November 15
Politics as Usual?
Credit Suisse published an in-depth report on the outlook for healthcare stocks in he context of the upcoming Presidential election cycle. Here are their views on how different biopharma industry groups might fare.
"Despite the healthy growth prospects, sector valuation will certainly meet substantial headwinds as political issues dominate investor concerns in the near term; otherwise our 5% sector valuation premium to the S&P 500 would be higher. Material risks have thus far been avoided (for example, FDARA), but uncertainty on non-interference removal (removing the barrier to centralized price negotiations by the Federal Government for Medicare), net impacts if universal healthcare would be adopted and follow-on biologics, keep investors cautious on the group."
Catherine Arnold
Analyst, Credit Suisse
November 20 report
"Generics are a defensive play and will do well regardless of who wins the White House."
Marc Goodman
Analyst, Credit Suisse
November 20 report
"Our biggest concern is that the presidential candidates will turn to the high prices of biotechnology products (particularly in oncology) as an area of focus for the rising cost of healthcare. While this discussion is possible, particularly from the Democratic leadership, we think it is unlikely."
Michael Aberman and Katherine Xu
Analysts, Credit Suisse
November 20 report