FTC wins another battle
By now, you’ve likely all read about the abandoned IQVIA-Propel Media merger. It’s a little beyond our coverage scope on Pharma Manufacturing, but still warrants some discussion given that it’s an example of the FTC’s deep reach into various corners of the pharma industry.
In case you missed it, life sciences intelligence provider IQVIA entered into an agreement with Propel Media to gain control of the company’s DeepIntent business, which provides advertising targeted at health care professionals. This advertising includes marketing prescription drugs.
According to a letter posted by DeepIntent’s founder and CEO, Chris Paquette, this agreement was inked in late 2022. In July 2023, the FTC sued to block the merger, claiming that the acquisition "would give IQVIA a market-leading position in programmatic advertising for health care products, namely prescription drugs, to doctors and other health care professionals.”
The companies tried to fight the legal challenge, but in late December, a judge granted the FTC’s request for a preliminary injunction. While Paquette was quick to point out that the ruling “was not a final decision on the merits of the FTC’s position that our acquisition would reduce competition,” he also said that given the “time, energy and resources” needed to litigate the matter, DeepIntent and IQVIA had mutually agreed to abandon the deal.
Sanofi found itself in a similar situation back in December. The drugmaker opted to back out of a licensing agreement with Maze Therapeutics after the FTC moved to block the $755 million deal, which was focused on a clinical-stage Pompe disease asset. Like DeepIntent, Sanofi disagreed with the FTC's monopoly concerns — but opted to terminate the deal to avoid prolonged and costly litigation.
For pharma, the recent IQVIA scenario is yet another reminder that the FTC has its eye on the industry’s deal-making — an issue that doesn’t appear to going away any time soon. —Karen Langhauser
Weight loss side effects pile up
Recent reports by CBS News revealed FDA-observed side effects, including alopecia and suicidal ideation, associated with weight management drugs.
These drugs, also known as incretins, have dominated headlines in the past two years. Addressing the U.S. obesity crisis, they offered hope amid a lack of effective treatments.
However, shedding pounds with these drugs may entail risks, as seen in concerns raised by the European Medicines Agency last year regarding suicidal ideation and gastric paralysis. Ozempic, for example, had been linked to thyroid cancer and gastrointestinal issues.
But while post-approval side effects may seem like FDA shortcomings, a 2017 study showed that alerts, warnings, or recalls affected about one-third of drugs approved within a decade.
Some issues, like warnings about drug interactions, were manageable, but others, including death, occurred. For example, a 2019 FDA warning linked febuxostat (Uloric) to increased cardiovascular death rates compared to allopurinol.
Safety issues may not be detected before approval due to differences between clinical trials and real-world usage. Clinical trials may exclude certain groups, but once approved, a broader population may use the drug, revealing new problems.
While alarming, these reports underscore successful post-approval monitoring. According to research shared exclusively with CNN by Epic Research, approximately 1.7% of individuals in the United States were prescribed a semaglutide medication in 2023, reflecting a 40-fold surge over the past five years.
So unfortunately, regardless of the sizeable data groups involved in clinical trials, the escalation in prescriptions and user numbers is likely to continue unveiling side effects. — Andrea Corona