AstraZeneca PLC

As the number of drugmakers exploring direct-to-consumer (DTC) models in the US increases, AstraZeneca announced on Friday the launch of its at-home delivery service for the seasonal influenza vaccine FluMist. And while the majority of similar DTC initiatives aim to lower the price of drugs — by eliminating middlemen in the supply chain — FluMist Home is designed to reverse the trend in declining flu vaccine rates, especially among younger people."The launch of FluMist Home is a transformational moment in the evolution of influenza protection," remarked Joris Silon, AstraZeneca's US Country President, noting that the programme "reflects the growing importance of direct-to-consumer offerings."First approved by the FDA in 2003, the agency okayed use of FluMist in September last year to allow self- or caregiver-administration in adults 18 to 49 years of age. In those aged 2 to 17 years, the nasal spray flu vaccine can be administered by a parent or caregiver.AstraZeneca said Friday that FluMist Home will allow individuals 18 and older to complete an online medical screening questionnaire, which will be reviewed by a licensed healthcare provider from specialty pharmacy ASPN Pharmacies. Once eligibility is confirmed and insurance is verified, FluMist will be prescribed and shipped directly to the consumer's home by another specialty pharmacy, Polaris Pharmacy Services.People with insurance will have to pay an $8.99 shipping and processing fee to obtain FluMist, while those without coverage can still purchase the vaccine for around $70.FluMist Home will initially be available in 34 states in the US for the 2025-2026 flu season. Local pharmacy laws in the remaining states prevent the introduction of the programme, although AstraZeneca hopes to circumvent these for future flu seasons.

President Donald Trump signed an executive order on Wednesday directing an office within the Department of Health and Human Services (HHS) to increase its supply of ingredients for "critical" drugs, part of his latest push to bring more facets of the pharmaceutical supply chain into the US. The order follows closely behind a new initiative unveiled by the FDA last week, called the PreCheck programme, designed to offer more support for groups seeking to build US production facilities.  Under the threat of steep tariffs that could reach 250%, Trump has spent the majority of his second term so far pressuring drug developers to onshore manufacturing — and broadly, big pharma appears to have complied, with about a dozen companies having announced plans to invest billions in US operations.Some of the heftiest financial promises were from European drugmakers, with AstraZeneca and Roche each pledging $50-billion investments. For more, see – Spotlight On: AstraZeneca puts its money where its mouth is.The most recent update came from AbbVie, which said Tuesday that it will invest $195 million to build a new active pharmaceutical ingredient (API) manufacturing facility at its North Chicago campus as part of a broader $10-billion commitment to bolster its US manufacturing.Now it seems the Trump administration is also homing in on the importance of APIs. Under the executive order, the Office of the Assistant Secretary for Preparedness and Response (ASPR) has been directed to first develop a list of 26 drugs deemed "vital to national health and security," and then ensure the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) is stocked with a 6-month supply of components for these treatments, preferentially using APIs made in the US. In addition, ASPR has been instructed to update a list of 86 essential medicines created in 2022, and draft a plan to secure a half-year supply for these drugs' relevant APIs as well. The office will also create a proposal for a second SAPIR. "Stockpiling APIs, which are lower-cost and have longer shelf lives, strengthens the nation’s ability to ensure access to critical drugs during emergencies," the White House said in a fact sheet for the executive order. "Restoring capacity for domestic production of essential pharmaceutical products is essential to safeguarding national health and security against global supply chain disruptions."The order comes as the Trump administration has raised concerns that the lack of US manufacturing leaves the country vulnerable to foreign supply chain disruptions. According to the fact sheet, only about 10% of APIs for US prescription drugs are manufactured in the country.A recent report from a US security commission found that in 2022, up to 28% of API imports were sourced from China, along with 90% of common medicines such as ibuprofen, hydrocortisone and acetaminophen."The United States is overly and dangerously reliant on foreign sources for our medicines and therapeutics," the National Security Commission on Emerging Biotechnology wrote.

Public Domain Citing other priorities—such as the upcoming U.S.-Russia summit—four anonymous sources claim that pharma tariffs could still be weeks away, according to Reuters . Despite months of threats that have ramped up in recent weeks, President Donald Trump’s sector specific tariffs on pharma are likely still weeks away, according to Wednesday report from Reuters . Citing sources familiar with the matter, the publication indicated that the results of an ongoing Section 232 national security investigation on pharma imports, as well as the final announcement of tariffs, are likely to come after the government’s final word on semiconductor tariffs, which is not imminent. Reuters ’ spoke to four anonymous sources, including a government official in Europe, someone with knowledge of internal happenings at the White House and two people at European drug companies. The White House source said that the government is preoccupied with other priorities, so an announcement on tariffs is unlikely to be made this week. Sources at the drug companies backed this up, noting that Trump officials are busy with an upcoming summit between the U.S. and Russia in Alaska. Meanwhile, the European government official said that tariffs are unlikely to be unveiled within the month, though the source nevertheless cautioned that timelines could still shift. Trump has been threatening the pharma industry for months now, and in recent weeks has made the matter top-of-mind once again with fresh warnings. In early July, he told reporters at a cabinet meeting that pharma imports could be hit with 200% levies , though he also hinted at a grace period of “a year, a year and a half” to allow companies to adjust their supply chains. Last week, however, Trump upped the ante and said that pharma tariffs could hit as high as 250% . Trump in July also arrived at a trade deal with the European Union, which sets the tariffs on pharma imports from the EU at 15%. Analysts expect even this relatively modest levy to cost the industry up to $19 billion in added expenses, but Jefferies has taken a more optimistic view of this announcement: 15% is “less bad” than what Trump had previously threatened and will have a “manageable” impact on companies, they wrote in a July 28 note. Running in parallel to trade talks and Trump’s public threats is the Department of Commerce’s Section 232 investigation, which Secretary Howard Lutnick launched in April and which will culminate in a report to the president, who will then decide whether to impose various trade restrictions, including tariffs. According to Reuters ’ reporting on Wednesday, Lutnick said last month that the probe could be finished by the end of the July, before pushing back his own deadline by two weeks. Faced with the threat of tariffs, several of the biggest pharma players have pumped billions of dollars into the U.S. to bolster their domestic manufacturing operations, including Johnson & Johnson , AstraZeneca and Roche .