Going Where The Problem Is – Insights From FDA/CMS Summit

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

By Rob Wright

If you want to make a difference in this world, you need to go where the problem is. This lesson was shared with me by the CEO of Celgene, Bob Hugin, at this year’s FDA/CMS Summit in Washington, D.C. Hugin, the chairman-elect of the Pharmaceutical Research and  Manufacturers of America (PhRMA), walked up to me prior to giving his keynote address on Tuesday, and gave me a quick education in problem solving.

CEO Still Applies Lessons Learned As Marine
When Hugin approached, I thanked the former Marine for his service. I then asked, “What lessons did you learn as a Marine that you still use today in your role as an executive of Celgene?” He replied, “I can remember it like it was yesterday.” Hugin proceeded to tell me that as a Marine officer, he was approached by a newly promoted Brigadier General to serve as his aide-de-camp for the soon to be Camp Lejeune base commander general in N.C. Hugin explained to the general that he wasn’t sure if he wanted to make a career out of the military. But if he did, he wanted to go back to the 3rd Marine Division. “I told him I wanted to be the tip of the spear, first to fight, to be deployed where I could make the biggest difference,” he said. In response, the general said, “Hugin, if you want to make a difference, you need to go where the problem is.” He proceeded to explain some of the problems taking place at home during the late 1970s, such as drugs in the barracks at Camp Lejeune. The general relayed to Hugin the importance of fixing problems at home first, before deploying the tip of the spear to solve problems throughout the world, and the best way to do this is going to the source of the problem.

Hugin still applies this lesson today, embracing the role of PhRMA chairman-elect, and going where the problems are, many of which take place in Washington. One of his greatest frustrations is policy making that is not supportive of innovation, i.e. the Independent Payment Advisory Board (IPAB), which Hugin sees as depriving the U.S. Congress of its role of oversight. Along with IPAB, there were a number of other controversial topics discussed, and highly regarded speakers willing to share their point of view, which refreshingly, was not framed up to be politically correct.

Controversial Cleveland Clinic Clinician
Healthcare reform, which took the form of President Obama’s Affordable Care Act of 2010, established IPAB – a 15 member panel of unelected federal employees, appointed by the president, confirmed by the senate, with the mission of cost reduction of Medicare payments, while maintaining quality – two goals which some believe to be in conflict. Steven Nissen, M.D., sees other goals in conflict. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, feels that accelerated drug approval should be rare, and questions the passing of the FDA’s breakthrough drug therapies designation. Rather than speeding a drug through approval, he would rather see innovation spurred by giving extra exclusivity to companies which develop drugs meeting an unmet medical need. When asked for his opinion on insurance companies wanting to be part of the innovation drug discovery process, as early as Phase 2 of clinical trials, he summed up his opinion with two words – “DROP DEAD.” In his opinion, insurance companies should not be involved in the process of drug discovery, and in doing so, sets a dangerous precedent. I am in totally agreement with Nissen on these points.  

Dangerous Precedent Or Free Speech
Another dangerous precedent Nissen sees is the recent ruling in the case of the United States v. Coronia. On Monday, December 2, 2012, the 2nd U.S. Circuit Court of Appeals overturned the conviction of a pharmaceutical sales representative for promoting off-label use of a prescription drug, finding that Alfred Caronia’s free speech rights under the First Amendment had been violated. Nissen would like to see this ruling overturned. Not all folks agreed with Nissen, including myself and Scott Gottlieb, M.D. A resident fellow at the American Enterprise Institute for Public Policy Research (AEI), Gottlieb supported the ruling, saying so during the afternoon Tuesday panel session in which he participated, as well as in the article he published here. Having performed the duties of a pharmaceutical sales representative for many years, I am in total agreement with Gottlieb, who believes the “FDA regime had become over-reaching, with the agency attempting to restrict the ability of sponsors to even share the results of major government-funded studies with physicians.” Gottlieb believes by over-interpreting its authority, the FDA invited challenge. Only time will tell if the same will be said for the decisions to be made by IPAB.