Regulatory/Policy Blogs


Shoppable Services: Price Transparency Era’s First Real Business Bellwether

Many pharma executive and marketing leaders actively monitor the pricing transparency conversation in search of the meaningful insights that can truly impact their business performance. And while much public attention has been paid to items such as “drug costs in TV commercials” and “CEO testimony before Congress,” little evidence exists that they have actually moved […]


EVP Wendy Blackburn: 5 Options for Managing the DTC Transparency Debacle

Drug pricing is a hot button issue, including the pricing transparency battle, and it’s not going away anytime soon. On July 8, U.S. District Court Judge Amit Mehta ruled that the Department of Health and Human Services had overstepped its authority in requiring pricing disclosures, stating, “That policy very well could be an effective tool […]


Complying With Colorado’s New Drug Price Transparency Law

This POV describes Colorado House Bill 19-1131 and how it could affect pharma marketers. The bill requires that any one-to-one communications between pharmaceutical representatives (or anyone communicating on their behalf) and prescribers must include written information about the wholesale cost of a drug, as well as the names of at least three generic equivalents. The law goes into effect on August 2, 2019.


California’s New Data Privacy Law: New Thinking on its Implications for Pharma

Last fall, we published a POV called “Should Pharma Care About California’s New Data Privacy Law?” Since then, we’ve been monitoring the legislative process and the discussions and reactions of opinion leaders. This updated POV provides the latest thinking on this law and its implications for pharma marketers.


Federal Judge: Full Stop on Drug Prices in DTC TV Ads

On July 8, U.S. District Court Judge Amit Mehta ruled that the Department of Health and Human Services had overstepped its authority in requiring pricing disclosures. What happens next?


FDA Finalizes Guidance on Mandatory Electronic Submission of Promotional Materials

On Monday, June 24, 2019, the Food and Drug Administration finalized its guidance on electronic submissions of promotional materials. This Intouch POV provides an overview of the most significant aspects of the guidance, including the most important changes from the 2015 draft version.


Five Issues in Washington for Pharma to Watch

At the Coalition’s Rising Leaders conference on healthcare policy in Washington, D.C. May 22, a diverse set of speakers provided updates and predictions, and discussed the potential impact of the many significant healthcare policy decisions pending on Capitol Hill. This POV provides an overview of five issues to watch that were highlighted at the conference, as well as strategies for addressing them.


What About YouTube? Streaming TV and the List-Price Mandate

In the wake of the May 8 list-price mandate for DTC TV ads issued by the Centers for Medicare & Medicaid Services (CMS) -- and, even before that, since the draft rule was issued in October 2018 -- one of the questions we are hearing from clients is, “What about YouTube?” Read on to learn more.


New List Price Mandate for DTC Television Advertising

On May 8, 2019, the Trump administration announced that the Centers for Medicare & Medicaid Services (CMS) would require drugs covered by Medicare or Medicaid to include a list price in any DTC television commercial within 60 days of the announcement, if their list price is at least $35 for a month’s supply or a course of treatment. The ruling is virtually the same as the one proposed in October 2018, and only products that advertise on TV are affected directly by the ruling. This POV provides a brief summary of the background to this ruling, a summary of its specifics, some reactions to it, and our recommendations to clients in its wake.


Pharma CEOs Face the U.S. Senate in Drug Price Hearings

The Finance Committee of the U.S. Senate held two hearings – one in January and one in February -- on “Drug Pricing in America: A Prescription for Change.” As we’ve seen them unfold, they’ve been reminders of ongoing tensions with the industry, and a harbinger of what may be on the horizon for pharma manufacturers.

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