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10 September
Trump tasks FDA to crack down on misleading drug advertising
The US is the only country besides New Zealand that allows direct advertising of prescription drugs to consumers. Credit: rblfmr/Shutterstock.com
US President Donald Trump is launching an enforcement drive against pharmaceutical companies and social media influencers who are responsible for “misleading” drug advertising.
The US Food and Drug Administration (FDA) is sending thousands of letters warning pharmaceutical companies to remove misleading ads, in addition to issuing around 100 letters to other companies demanding they pull deceptive marketing.
The drive is via a presidential memorandum in which Trump has tasked health secretary Robert F Kennedy Jr (RFK Jr) to clamp down on direct-to-consumer prescription drug advertising. This includes increasing the amount of information regarding any risks associated with using the medicine.
The political spotlight turned on drug advertising in the wake of a controversial advert aired by telehealth company Hims & Hers during this year’s Super Bowl final. The advert advocated for its compounded weight loss drugs while attacking rival products from Big Pharma. The commercial drew criticism from senators while regulators said that side effects were not properly explained during the commercials.
5 September
Five takeaway quotes from RFK Jr’s combative Senate hearing
US Health Secretary Robert F Kennedy (RFK) Jr has been pressed on his changes to vaccine guidelines, firings at health agencies, and Covid-19 viewpoints in a fiery three-hour-long congressional hearing.
In what were arguably the most combative proceedings to play out before the Senate so far this year, the US Department of Health and Human Services (HHS) chief testified before Democratic and Republican senators on a range of health topics and many of his policies that have engulfed the administration in a bipartisan storm.
In his opening statement, RFK Jr promptly addressed the shakeups at the US Centers for Disease Control and Prevention (CDC) that have engulfed Capitol Hill in a political storm. Last week, the health secretary fired CDC director Dr Susan Monarez.
At least three senior CDC leaders have since resigned from the agency, citing disagreement over vaccine policy and HHS leadership.
11 September
UK pharma industry risks losing world-leading status as investment plummets
The UK is at risk of losing its world-leading life sciences status due to investment being captured elsewhere on the international stage, according to trade body Association of the British Pharmaceutical Industry (ABPI).
In its latest ‘Creating the conditions for investment and growth’ report, the ABPI detailed the alarming drops in foreign direct investment (FDI) and R&D funding. The body states that this means the UK is lagging in the global race for investment, with significant economic consequences.
The pharmaceutical industry is critical to the UK Government’s long-term plans to boost the life science sector, contributing £17.6bn in direct gross value added (GVA) annually to the economy. However, the ABPI called on ministers and the pharma industry to share an aligned view about the factors driving investment. This view has often diverged, creating an uncertain life sciences scene in the country between the government and key pharma players.
17 September
Eli Lilly picks Virginia for $5bn drug manufacturing plant
Eli Lilly has revealed the foremost plans from its new swathe of new drug manufacturing facilities it aims to build across the US, with Goochland County, Virginia, confirmed as the location for the first plant.
Goochland County is located in central Virginia, bordering the state’s capital city of Richmond on its northwestern side.
The $5bn manufacturing facility will be Eli Lilly’s first “dedicated, fully integrated” active pharmaceutical ingredient (API) and drug product facility for the big pharma company’s bioconjugate platform and monoclonal antibody (mAb) portfolio.
The site will also boost Lilly’s domestic manufacturing of antibody-drug conjugates (ADCs), a modality with growing use in cancer treatment.
Lilly does not have a US Food and Drug Administration (FDA)-approved ADC but has multiple assets in clinical trials.
8 September
WHO adds GLP-1RAs to essential medicines list
The World Health Organisation (WHO) has updated its model list of essential medicines (EML) to include four key obesity and type 2 diabetes (T2D) drugs.
This includes Novo Nordisk’s semaglutide, marketed as Ozempic and Wegovy for T2D and weight management, respectively, as well as Eli Lilly’s tirzepatide, marketed as Mounjaro and Zepbound, again in T2D and weight management, respectively.
The United Nations (UN) agency has added the glucagon-like peptide-1 receptor agonists (GLP-1RAs) and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists to the EML following a review from the WHO Expert Committee, which found “strong scientific evidence” to support their benefits in patients with T2D.
However, WHO raised concerns about the costs of both semaglutide and tirzepatide, which come with a hefty price tag of between $997 and $1349 for a one-month prescription in the US, which the agency warns could complicate patient accessibility.