- Scott Gottlieb won Senate confirmation and was sworn in as FDA commissioner last week. Here’s how his appointment might affect pharma digital (tldr: expect a more hands-off approach to regulation of digital communication and digital therapeutics – and likely more explicit guidance on these topics).
- Another area where Gottlieb might have an impact is in FDA’s willingness to weigh real world data in evaluating medications. Last week, GSK announced favorable results from a real world study of Breo for asthma, echoing an earlier study for COPD (the two studies combined reportedly cost GSK around $100 million, which would probably compare favorably with clinical trials for a big drug). These sorts of studies, though not admissible for the marketing of new medicines, could bolster brands seeking new indications, per the 21st Century Cures Act, or help persuade payers to grant more favorable status. The sped-up approvals system envisioned by the White House could prove costly, and payers will be eyeing approved medications with more scrutiny.
- Postmarketing studies like GSK’s may be more in demand going forward, as FDA looks to juice up the rate of new drug approvals, trading some safety for speed in the process. A Yale study found that nearly 1 in 3 drugs approved between 2001 and 2010 saw safety events including boxed warnings, safety alerts and withdrawals.
- Under fire for failing to hold down drug prices, Express Scripts is partnering with several large pharmas to offer a discount program, dubbed InsideRx, offering steep discounts (34%, on average) on certain medications to patients who do not have insurance or face punishing deductibles.
- Also under fire for failing to rein in untoward price hikes, PhRMA tightened up its membership policiesto require that members plow 10% of global sales on R&D and invest $200 million on developing new drugs over a 3-year period – jettisoning 22 member companies in the process.
- Branded drug prices rose an average of nearly 13% last year, as pharmas continued to lean on price hikes to keep quarterly financials looking healthy, bad press and Senate hearings be damned. Meanwhile, the World Health Organization is working on a global fair pricing framework for prescription drugs.
- Sanofi pledged to peg US price increases to the medical inflation index, saying “complexity [in the pricing system] is undermining the reputation of an entire industry whose purpose is to make a positive change in patients’ lives.”
- Sanofi is also partnering with an AI firm to develop small molecule drug candidates for diabetes.
- Sermo has introduced a drug ratings feature they’re billing as “the first global doctor-to-doctor drug ratings tool,” leveraging their reach with physicians to establish what our friends at Klick Wire call the new “gold standard” of ratings sites. They’ve stocked the pond with more than 250,000 ratings – mostly U.S. so far – of more than 2,000 drugs. For pharmas, Sermo is offering ratings reports for purchase and sponsored links.
- “Text messaging is inevitable,” writes a physician in JAMA, noting that doctors are communicating with patients through texts despite a lack of clarity on how to do so securely. Interesting look at what instruction HIPAA does and does not offer physicians here.
- Bayer has gamified its salesforce training for Betaseron with RepRace, a sales sim game aimed at helping reps more deftly engage physicians.
- A startup making medical Apple Watch apps presented study results showing that their algorithm detected Afib with 97% accuracy in Apple Watch users.
- Here’s an adherence tech startup offering pharma brands cobranding on a machine learning-informed platform that it claims is capable of pushing out side effects or financial assistance info in a timely fashion or prompting nonadherent patients to call a nurse hotline.
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