The Wharton alum leads the U.S. government relations and public policy team for Shire, the global biopharmaceutical company whose goal is to enable people with life-altering conditions to lead better lives. He and his group are responsible for shaping the policy environment that enables Shire’s delivery of value to patients, physicians and shareholders. Shire has five different areas of concentration, and certainly medications like Vyvanse, created by Shire and used to treat attention deficit hyperactivity disorder, is widely used by a large patient population. But the company also develops medications for diseases whose sufferers might number 10,000 or fewer worldwide.
New medications typically take about 12 years from discovery to regulatory approval, and government has a presence for nearly the entire process—in funding basic research, issuing patents, granting FDA approvals—making Buckley’s job critical to ensuring a smooth journey. “You do that in a lot of different ways,” he says. “We try to take a collaborative approach to engage in a substantive way with policy makers, to be seen as part of the solution instead of part of the problem.”
This can mean lobbying for a better-funded FDA, “which does a great job with the resources they have, but they are under-resourced.” Sometimes it involves developing alliances with other companies or patient advocate groups whose interests align with Shire’s.
Recently, much of Buckley’s energy has gone into a response to proposed tax reforms that could threaten the development of drugs aimed at rare diseases. Because relatively small sales await such drugs, the U.S. government in 1983 enacted tax breaks to encourage drug companies to develop products for rare diseases. The Orphan Drug Tax Credit (ODTC) has been enormously efficacious. In the decade prior to 1983, ten such drugs and biological products emerged. Since the ODTC, more than 300 have been brought to market—including drugs for Huntingdon’s Disease, Gaucher Disease, neuroblastoma, and infant respiratory distress syndrome.
“It’s a tax credit that has really helped to save lives. With U.S. tax reform discussion underway, it’s important for policy makers and politicians to realize what the effect would be if they did away with it. It would change the internal calculation for our product investments. And while patients are at the heart of everything we do, we also have a fiduciary responsibility to our shareholders.”
Buckley concedes that pharmaceutical companies in general suffer from an image of being driven by profit, but profit on today’s successes, he points out, pays to invent tomorrow’s medications that save and improve lives. “In the 1970s you always heard about people going into the hospital for surgery for bleeding ulcers. That’s not the case today. Pharmaceuticals changed that. With HIV—from 1995 to 1997, the death rate dropped by 64 percent, and that was the protease inhibitor cocktail. I know people whose lives were saved by those drugs. I think we suffer because it is a complex industry, and we live in an age of sound bites, and trying to explain things to people is sometimes very hard.”
Buckley says it takes about $1.2 billion to shepherd a drug from conception to approval and distribution. “There’s a saying that the first pill costs $1.2 billion and the second pill costs next to nothing, but nobody wants to pay for the first pill.”
Buckley was a math major at Penn. A year out of college, he took a job in Canada at L’Arche, a worldwide network of communities in which people with and without developmental disabilities live together. “I was fascinated by the way in which Canada approached social services … and intrigued by the intersection of government and policy and business.” He came back to the U.S., took courses at Penn’s College of General Studies—one in economics and healthcare, the other in the economics of public policy—and decided to go back to school full-time. He ended up with two Wharton degrees: a master’s, and a PhD in Applied Economics, and was a National Center for Health Statistics NCHS/AcademyHealth fellow while completing his dissertation. He worked as a consultant at McKinsey and Company, where he advised health insurance and pharmaceutical companies. Just prior to Shire, he was chief economist at Bloomberg Government, where he set up and led the analytics team in measuring the impact of government actions on a wide variety of business sectors.
“But I really became hooked on the whole healthcare system and how every government is trying to fix it,” he says. “The reason the healthcare system is not a well-functioning marketplace is this: In a well-functioning marketplace, a man goes into a restaurant, orders a meal, pays for his meal and eats his meal, and all of his incentives are aligned. It’s price versus taste versus nutritional value, and he balances and aligns those things. In the healthcare market, three people go into the restaurant, one orders the meal, one eats the meal and one pays for the meal. And if you think of the number of ways in which incentives can play out in that situation, it’s staggering. To get those to align is, I’d say, very challenging. And government keeps trying.”
Frustrating? Absolutely, Buckley says.
“To me, from an intellectual standpoint, it’s fascinating—how could you ever get bored thinking about these problems? But it’s sort of an intractable problem, and at the end of the day I find it really, really worthwhile, because I helped to create an environment where needed treatments can be researched, developed and brought to market. And that’s pretty cool.”