That's the message that a southern New York district judge sent to Eli Lilly and its sales reps in a recent court ruling.
That's the message that a southern New York district judge sent to Eli Lilly and its sales reps in a recent court ruling. Judge John Koeltl agreed with the plaintiff, the former Zeneca Pharmaceuticals, that Eli Lilly and Co. was unfairly promoting its anti-osteoporosis drug Evista® (raloxifene) to physicians for the prevention of breast cancer. (Since the lawsuit was filed in February, Zeneca merged with Astra Pharmaceuticals and is now known as AstraZeneca.)
According to present FDA standards, only pharmaceutical companies that receive FDA approval for specific indications can mention those indications to physicians during sales calls. Although a large-scale clinical study has suggested that Eli Lilly's product could be effective in preventing the disease, only tamoxifen - the clinical name of AstraZeneca's Nolvadex® and the primary ingredient of Barr Laboratories' generic equivalent to Nolvadex - has received approval from the FDA for this indication. Therefore, only AstraZeneca and Barr sales reps should mention this benefit when speaking with physicians about tamoxifen.
Consequently, Judge Koeltl ruled that Lilly should stop "stating in its advertising or promotional activities that Evista has been proven, shown or demonstrated to reduce the risk of breast cancer, or that Evista has been proven comparable or superior to tamoxifen in the reduction of the risk of breast cancer."
The judge also ruled that Eli Lilly must implement an internal training program for its sales reps to correct any errant promotional activities they might engage in regarding Evista and its role in breast cancer prevention. The company does not have to change any of its advertisements, however, as Zeneca had originally requested.
In a formal statement, Eli Lilly said that the ruling "will not impact Lilly's ability to detail physicians or affect product performance." The company also stated that it "does disagree with the Court's opinion in several respects" and "is reviewing all legal options," including an appeal. PR
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
October 25th 2024Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.
The Transformative Role of Medical Information in Customer Engagement
October 3rd 2024Stacey Fung, Head of Global Medical Information at Gilead Lifesciences, delves into the evolving role of Medical Information (MI) in the pharmaceutical industry. Covering key topics like patient engagement through omnichannel strategies, combating misinformation, and leveraging AI to enhance medical inquiries, the conversation with Stacey highlights MI's critical role in ensuring patient safety and supporting drug development. She also shares her professional journey and tidbits for early career professionals on professional development.
The Impact of Artificial Intelligence on the Creation of Medicines
October 24th 2024Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.