The FDA is grossly underfunded, resulting in spotty oversight and slow drug approval processes, leading some to speculate that America might be better served by two agencies instead: one for food safety and another for drug oversight.
But today industry insiders* downplayed the idea of carving up the FDA. Their reasoning? First of all, it would be too complicated to untether the two areas of oversight. Secondly, America is redoubling its preventive health efforts, including healthy eating and regular exercise as a means to reduce the chronic disease burden. Billy Tauzin, CEO of PhRMA, commented, “We are what we eat. We should keep food and drug oversight closely aligned.”
Other industry concerns voiced on the conference call included:
1. A wish for the FDA to enter the 21st century by accepting digital filing and analysis of clinical trial data. Currently, they accept paper copies only.
2. A call for an experienced executive leader to become the new FDA Commissioner. One conference participant stated that “The FDA has been a rudderless ship for too long. We need someone who has the courage to say that there’s no such thing as a risk-free drug, and then speed up the approval process based on the best science available. The FDA is the world’s leading regulatory agency but is losing respect on the international stage, while Europe’s FDA equivalent is increasing in prestige.”
3. A desire for the new FDA Commissioner to be “above politics” and objective about science. A fixed term for the position was proposed.
4. A request for transparency in the drug approval process. One call participant said, “The FDA’s decision-making process is a black box. That really slows down our ability to get effective drugs to market.”
5. A cautious approach to approving biosimilar (or follow-on biologics) treatments. “At least 14 years are needed to demonstrate the interchangeability of biologic therapies,” said one biotech industry leader. “There’s a big difference between creating generic molecules of a common drug, and reproducing safe and effective treatments derived from living organisms.”
*The conference call was called, “The Obama administration and the new congress: good medicine for the pharma, biotech, and medtech industries?” sponsored by Ernst and Young. Recordings of the conference are not yet available to the public. Participants included:
Billy Tauzin, President and CEO of PhRMA
Jim Greenwood, President and CEO of the Biotechnology Industry Organization
Brett Loper, Executive Vice President, Government Affairs from AdvaMed
Mark B. Hassenplug, Global Pharmaceutical Markets Leader, Ernst & Young LLP
Anne Phelps, Prinicpal, Washington Council Ernst & Young LLP
Carolyn Buck Luce, Global Pharmaceutical Sector Leader, Ernst & Young LLP
Billy Tauzin has spent most of his life in politics. He has been a member of the House of Representatives as both a democrat and a republican, though his recent experience with a rare and usually terminal cancer (duodenal adenocarcinoma) radically changed his career path and trajectory. I caught up with Mr. Tauzin by phone at the America’s Agenda conference in Miami. You may listen to our podcast conversation or read my summary of our discussion below.
Dr. Val: Tell me a little bit about your intestinal cancer and how that changed the course of your life.
Tauzin: I was in the process of finishing up a 25-year career in Congress when one night I had a sudden, massive bleed. I was taken to the hospital and was diagnosed with a rare cancer with a poor prognosis: duodenal adenocarcinoma. There was a hole in my intestine, right next to my pancreas.
I went to Johns Hopkins to have a Whipple procedure – and as you know a Whipple procedure is one of the most aggressive types of surgery anyone can endure. They kind of split you open like a fish, pull out your innards and restructure you. They had to remove part of my stomach, intestines, and pancreas, and then reconnected it with new ducts and channels. The Whipple was supposed to cure me, but unfortunately I found out (at a follow up visit at MD Anderson) that there was still cancer in my body.
The doctor told me very frankly that I was going to die.
Dr. Val: Tell me about the experimental drug that you were introduced to at that point.
Tauzin: My doctor reviewed my options with me: I could undergo another surgery, but that would probably kill me and would be unlikely to cure the cancer. They had no approved protocol for people in my position, but there was a drug (called Avastin) that had been successful in treating colon cancer – but was not yet approved for duodenal adenocarcinoma. The drug works by cutting off the blood supply to tumors – which meant that the drug could either damage my healing process or kill the cancer. My wife and I decided to take the risk because we had very little to lose. It was really a choice between “going to die” (my current situation) and “might die” (Avastin could cure me).
It’s a good thing we tried Avastin because it worked like a miracle. By the end of my first round of chemotherapy, the radiologist couldn’t even find the tumor on my CT scans. It was gone. I completed several courses of chemo and radiation and I’ve been cancer-free for over 5 years now.
Dr. Val: Did this miraculous recovery influence your decision to become the CEO of Phrma?
Tauzin: After I recovered from cancer, I was fortunate to be offered many different job opportunities. However, my wife looked at me and said, “You know Billy, you really ought to go to work for the people who saved your life.” And I thought, “If there’s a meaning in why I’m alive today – then surely it must be to use my experience to help patients like me across the world.”
Dr. Val: So what are you hoping to achieve at the America’s Agenda conference in Miami?
Tauzin: This conference is unusual in that we’ve gathered together a group of very disparate voices from different perspectives – labor, business, health plans, trade associations, academic medicine, etc. hosted by Donna Shalala (former Secretary of HHS) at the University of Miami. We are trying to define our commonalities so we can influence health reform more effectively.
Washington is all about differences – it’s partisan, it’s mean, and I’ve been on both sides of the aisle. I can tell you that there are good people in both parties, but they’d never know it because they consider each other enemies. What we’re trying to say here is: patients don’t sign in as democrat or republican when they register at a hospital. They sign in as sick people. This is not a partisan issue. We have a sick care system that needs to be a health care system.
Dr. Val: What should the Obama administration choose as their top priorities for health reform?
Tauzin: First of all we need to recognize that we spend 75 cents of every dollar on the damage done by 5 chronic diseases (including diabetes, heart disease, mental health, cancer, and lung disease). We must focus our system on early detection and prevention of these diseases, so that we manage them well and avoid the costly toll they take when untreated. We’re destined to be a poorer, sicker society if we don’t get insurance coverage for every American. We need insurance to provide early detection, prevention, and good management of our chronic diseases. How we do that is debatable. But we need to get there.