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With a new administrator at the helm, the U.S. Food and Drug Administration took steps toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more...the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape...the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. Here's a rundown of the agency's actions and announcements during 2017.

• New leadership, new approaches
  ...a plan that included clear language on which devices the agency would look to regulate, an app regulation strategy involving postmarket data collection, and other idea designed to streamline the approval process...FDA opened up applications for a pilot of a firm-focused digital health pre-certification program...nine companies selected to participate: Apple, Samsung, Verily, Pear Therapeutics, Tidepool, Phosphorus, Fitbit, Roche, and Johnson & Johnson...draft of the long-awaited and somewhat controversial guidance on clinical decision support, which laid out the forms of clinical decision support that would or wouldn't be regulated based on the degree of human involvement (as opposed to risk)...draft guidance describing the FDA's new Breakthrough Devices Program...would supersede the Expedited Access Pathway and aims to push novel technologies presenting a significant improvement over status quo through the clearance process more quickly.

• FDA shifts toward digital, patient feedback
  ...the Clinical Trials Transformation Initiative – a public-private partnership of pharma companies, academics, and regulators including the FDA – released new endpoint recommendations for the use of mobile technologies in clinical trials... The guidelines, meant to be the first in a series of such documents, included suggestions for study designers when selecting novel endpoints, practical approaches when developing these endpoints...

Disasters, both natural and manmade, wreaked havoc on pharma supply chains this year, exposing vulnerabilities and costing the industry hundreds of millions, if not billions, of dollars...Hurricanes took out power and plants in Puerto Rico...Less visible but much more sinister was the cyberattack that managed to penetrate systems at Merck & Co...Experts say both kind of threats are only going to get worse...Some natural disasters, like earthquakes, don’t follow seasons and can’t be tracked. They just happen...The FDA pointed out that the Federal Food, Drug, and Cosmetic Act, does not include a specific provision giving the agency the authority to require a contingency plan for preventing drug shortages if a facility goes offline, regardless of the cause...Some events have nothing to do with weather or geography. Merck was the only drugmaker to publicly acknowledge that it had not adequately protected its computer systems and was a victim of the Petya cyberattack...Expect this trend to continue in 2018...the disruption caused by ransomware to industrial organizations in 2017 didn’t directly affect the automation controllers, “we expect that a new, more damaging type of ransomware will specifically target controllers” in 2018...if those threats were not enough to keep pharma executives up at night...the chilling observation that North Korea, “has quietly developed a cyber army capable of unleashing attacks against critical infrastructures that could have global implications.”

When pharmacy professionals, rather than doctors or nurses, take medication histories of patients in emergency departments, mistakes in drug orders can be reduced by more than 80 percent, according to a study led by Cedars-Sinai...Cedars-Sinai now assigns pharmacy staff members to take medication histories for high-risk patients admitted to the hospital through the emergency department...Injuries resulting from medication use are among the most common types of inpatient injuries at U.S. hospitals, affecting hundreds of thousands of patients every year. Errors in medication histories contribute significantly to such problems, and those errors can lead physicians to order the wrong drug, dose or frequency.

The pharmaceutical industry is beginning to invest in artificial intelligence (AI), with many large pharmaceutical companies partnering with AI start-ups in 2017 in order to develop better diagnostics or biomarkers, to identify drug targets and to design new drugs. But when will the first AI-designed drugs reach the market and will AI permanently change the pharmaceutical industry and the way drugs are discovered?...Harnessing the power of modern supercomputers and machine learning will enable us to develop medicines more quickly, and at a reduced cost...The technology has just taken off recently and primarily that’s due to the advances in deep learning that have demonstrated superhuman accuracy in image recognition and autonomous driving...We are starting to see AI can outperform humans when analysing very complicated datasets for high content, phenotypic drug discovery...The [AI] technology is allowing us to explore a much bigger design space and discover these rare molecules that have properties beyond what we would get if we just ran a traditional high throughput screen...We can benefit from computer modelling but we still need to conduct real experiments and there will still be an element of serendipity...

With $200 billion lost to counterfeit drugs annually and patient safety issues, a chain-of-custody log that blockchain could enable holds promise...Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular...The distributed ledger technology could offer legislative, logistical and patient safety benefits for pharmaceutical supply chain management. From a regulatory perspective in the United States, blockchain technological and structural capabilities, in fact, extraordinarily map to the key requirements of the Drug Supply Chain Security Act...The DSCSA outlines a 10-year timeframe that will require elements including medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to enable each of these steps is a foundational aspect of blockchain technology...“Logistically, blockchain aligns well with federal efforts like the National Strategy for Global Chain Security,”...“One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labeled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice as many novel medicines as in 2016, yet returns on research investment at leading pharmaceutical companies are down...In fact, projected returns at 12 of the world’s top drugmakers have fallen to an eight-year low of only 3.2 percent...The disconnect reflects the rising cost of developing new drugs, meager peak sales expectations for individual products and the fact that younger biotechnology companies are accounting for a growing proportion of new products...So far this year, the Food and Drug Administration...has approved 41 novel drugs compared with 22 for the whole of 2016...It’s been a great year for approvals in 2017...But for the giants of the pharma world...things are not so rosy. This decade has seen shrinking profitability in their research labs, with the average internal rate of return down sharply from 10.1 percent in 2010 to 3.2 percent this year...A separate group of four large biotech companies are projected to enjoy an IRR nearly four times higher at 11.9 percent. The calculations are based on long-term sales forecasts...The biotech companies are seeing more success...biotechs typically had a leaner cost structure...