Although July 4 celebrations have come and gone, fireworks continue in the Martin Shkreli case, in which the defendant continues to mock prosecutors on his Facebook page. While the battle between Pharma Bro and the DOJ rages on, Senate Majority Leader Mitch McConnell has taken a decidedly more collaborative approach, suggesting that the GOP should consider working with Democrats to stabilize the Affordable Care Act in the absence of a successful repeal and replace plan. But we’re not betting on the opposing parties to break out in a group rendition of “kumbaya” anytime soon.
And don’t be fooled into thinking that issues are slow this summer—there is a busy week ahead, including a much-anticipated FDA workshop to review the science behind abuse deterrent drug formulations, one of the critical pieces in America’s battle to contain the opioid crisis.
No matter whether you were the lone staffer in your office or relaxing on a beach somewhere this past week, we’ve got the run down on the latest healthcare headlines—the good, the bad and the ugly—to help you get you back up to speed. Read on for the latest in The Week That Was…
DOES PHARMA MONEY TALK WHEN GIVEN TO KOLS?
Findings from two studies released last week examine payments made by pharmacos to healthcare providers and seek to renew scrutiny on the intricacies of relationships between the two. The Centers for Medicare and Medicaid Services (CMS) released data on 2016 payments by pharmaceutical companies to doctors. Despite anticipation that spending might decrease as a result of new reporting requirements, findings point to relatively consistent levels of payments in the $2.68–$2.8 billion range for meals, speaking engagements, and consulting from 2014–2016. The Mayo Clinic also published an analysis of industry payments to experts who speak on behalf of a pharmaceutical company before the Oncology Drug Advisory Committee as part of the review of a cancer drug. The analysis found that more than 9 out of 10 experts received industry payments and that there was a strong correlation between payments made and the number of times a physician has been published. Media found the analysis to be “particularly troubling” because of the strong influence of these experts in the field.
For those who believe the truth is stranger than fiction, we tend to disagree. In fact, the truth can often be pretty boring—and this is especially true when it comes to physician payments. Many hands were wrought before the passage of the Sunshine Act, which requires disclosure of pharmaceutical companies’ payments to physicians. But now that Sunshine has been in place for nearly seven years, have we seen many exposes on payment driven bias? Nope.
Most companies’ engagements with KOLs are for clear and appropriate purposes. We suggest disclosing such payments in clear and searchable channels—as it removes the halo of opacity and allows the company to provide context. For oncology developers, particularly those with a product nearing FDA review, in light of the Mayo Clinic report, you should be prepared with Q&As that explain relationships with key opinion leaders and their purpose, in case asked.
FDA DIPS TOE INTO PRICING DEBATE WITH PROMISE FOR MORE GENERICS
Sixty days into his term as FDA Commissioner, Scott Gottlieb has committed his agency to take action on prescription drug prices—that is, within its existing powers. While the FDA does not have a direct role in pricing, the agency is seeking to save system costs by pursuing new paths to make generic medicines available faster. The operating theory is that when at least three manufacturers produce a generic compound, the price falls significantly compared to the branded medicine. The FDA is hosting a public meeting on the topic on July 18th, and has announced a new policy to expedite review of generic applications if competition is limited.
The increasing emphasis on generics will put some branded manufacturers in the spotlight, especially those approaching the end of their patent rights. The agency may announce steps to compel branded medicines makers to provide supply so that generic manufacturers can study—and ultimately copy—the molecule. It’s also possible that sole-supply arrangements, and closed distribution networks among generic drugmakers will face increased pressure. These topics were included in a Senate Aging Committee investigation on sudden generic price increases issued in December, and given Gottlieb’s stated commitment to increasing competition through genetics, we expect Congress to revisit these issues throughout the year.
Until next week,
– The Issues Management Practice @inVentiv Health Communications