Posts Tagged: "New Drugs"

Nothing clarified the stakes in orphan drug development like hearing Ron Bartek describe how after 16 years a promising treatment for his son’s disease finally emerged with TRND’s help. The therapy demonstrated enough potential that it was licensed by a small company which took it through Phase I and II trials. Both showed very promising results. Ron choked up describing how he felt after such a long struggle to help his child and finally seeing a real glimpse of hope. Everyone in the room shared the lump in his throat. A day like that reminds you why tech transfer and intellectual property are so important. When used correctly they improve and protect lives all around the world.

It is nearly universally accepted (and for a reason) that the process from discovery to market is long and costly. Drugs to not invent themselves and there are significant costs associated with nearly 13 to 14 years awaiting approvals. But even that really doesn’t capture what transpires in reality. Pharmaceutical companies do not just passively wait for approval, they are required to take significant and costly affirmative steps. So the critics can do all the mathematical trickeration they want, they can bemoan tax incentives not being taking into account and further complain about pharmaceutical companies partnering with Universities to discover the next generation of life saving and life prolonging drugs. But if you are going to factor into the analysis tax incentives then you absolutely need to factor in the time-value of money into the equation, as well as the astronomical failure rate, which creates extraordinary risk.

Capitol Hill is frequently the setting for both grandstanding and pandering, and given the prevailing political and public sentiment it is also frequently a place where businesses find an inhospitable welcome. A recent case in point: Three senior members of Congress (Henry Waxman, Frank Pallone Jr., and Diana DeGette) have started a joint investigation into the pricing of Sovaldi, a breakthrough drug for hepatitis C produced by Gilead Sciences. Rather than applaud the health benefits that this drug will deliver, Congress is grilling the company on their pricing decision, striking fear in the investment community, and indirectly undermining the healthcare innovation that is so desperately needed.

In a moment of extreme weakness, I agreed to Gene’s request to doing a primer on Paragraph IV Certifications under the Drug Price Competition and Patent Term Restoration Act, commonly referred to as Hatch-Waxman. I don’t know if you would call me an expert, but I’ve studied many, many cases involving Paragraph IV Certifications under Hatch-Waxman. The courts have found Hatch-Waxman to be a hydra-like monster with a labyrinth of sections that are frequently confusing (or worse yet, conflicting). Paragraph IV Certifications are a particular trouble spot in Hatch-Waxman. So if you’re up to diving into the “belly of this beast,” let’s examine the characteristics of this most infamous of the Hatch-Waxman monsters. To understand Paragraph IV Certifications, you must first address what an Abbreviated New Drug Application (ANDA) is. ANDAs are how generic drug manufactures expedite the approval of their generic drugs.

Senator Ron Wyden (D- OR) is a man with an idea for lowering health care costs. Unfortunately, it’s an idea which proved disastrous the last time it was forced on the National Institutes of Health. But that hasn’t dissuaded the Senator from trotting it out again. He seems sincere in his concern with the ever escalating costs of medicine. Unfortunately, his proposed solution empowering the government bureaucracy to second guess industry drug pricing decisions simply because they worked with NIH would make things worse. We could see fewer new drugs at any price.