By the FDA’s own admission, the process for trialing and approving drugs for sale in the United States is incredibly complex and arduous. Most of the promising compounds that begin the clinical trial process fail to win approval. It’s easy to spin this as a good thing by proclaiming, “we don’t want Americans exposed to bad drugs.” But a growing chorus of policy experts and medical professionals — not just pharmaceutical reps, mind you — believes that the FDA now goes too far. The trial-and-approval process is so tough that many biotech and pharmaceutical companies, particularly smaller, scrappier entities without billions of dollars in capital reserves, simply forgo drug development altogether rather than risk a costly, reputation-damaging failure. The Basics of...

Unless you’ve been oblivious of the political conversation since the beginning of Barack Obama’s presidency, you’re likely aware of a law known as the Patient Protection and Affordable Care Act (PPACA). PPACA is also known as the Affordable Care Act (ACA), but most folks know it simply as Obamacare. Whatever you call it, the ACA dramatically reordered the American healthcare landscape, which was already changing rapidly. Legal experts like Philadelphia attorney David DelCollo can argue interminably about the legal merits and inconsistencies of the ACA, but most people on the street simply want to know how it affects them in practical terms. Needless to say, some folks are up in arms about the ACA’s perceived drawbacks and possible long-term deleterious effects:...

David DelCollo is an accomplished attorney with an extensive background in corporate, contract and healthcare law. After graduating from the Widener University School of Law in Harrisburg, Pennsylvania, DelCollo took an in-house counsel position with a mid-size IT firm in Philadelphia, Pennsylvania. He subsequently moved to North Carolina to serve as counsel for the state’s largest HMO. Upon rediscovering his Keystone State roots and putting aside his preference for mild weather, he accepted his current role as counsel with a well-known pharmaceutical firm and relocated back to the Philadelphia area.   When he’s not immersed in the minutiae of healthcare law, DelCollo acquires and refurbishes vintage motorcycles at his shop in the Philadelphia suburbs. He’s...

Who’s afraid of a little contract dispute? Literally every American business owner, that’s who. Philadelphia attorney David DelCollo built the first part of his career on a solid foundation: contracts, contracts and more contracts. And he’s not sorry he did it. “I was fortunate to be responsible for negotiating and enforcing contracts for two rather large organizations — one in the IT industry, the other in healthcare — early in my career,” says DelCollo. “Actually working in the trenches on these issues was an incredible experience that informs my work to this day.” DelCollo is permitted to practice in the state of Pennsylvania, making him familiar with the laws on the books in that state. “Pennsylvania contract law is, frankly, quite complicated,” he says. “Our...