FDA To Outline mHealth Guidelines In 2013
Mobile health apps are gaining momentum and saturating the healthcare market, so it's no wonder the FDA is looking to set guidelines in place to regulate this booming sector. Many consumers are beginning to trust these applications as much as they would a physician, and many healthcare professionals are utilising mobile tools for information and file sharing.
The FDA testified before the House Energy and Commerce Committee this week, where it was asked how it plans to ensure mHealth apps are useful, standardized and accurate. The Committee also questioned how the FDA would regulate apps utilised by physicians and those, which integrated into electronic health records.
The FDA issued a draft in 2011, however it is yet to finalize its rulemaking. Furthermore, the firm is still making decisions about the tax status of mobile devices and health apps. The Committee cited tax as one of its major concerns; under the Affordable Care Act, regulated medical devices are subject to a 2.3 percent excise tax. If the FDA determines that mHealth apps, tablets and smartphones fall under that category, they could be forced to pay the additional amount, which is enough that some industry experts believe it could stifle mHealth innovation and development.
“Revenues [from mHealth development] are ploughed back into the company for growth, therefore the 2.3 percent tax on startup companies increases the amount that must be invested before companies become cash-flow positive,” said Dr T Forcht Dagi, Partner at HLM Venture Partners.
App developers have been eagerly awaiting a set of guidelines from the FDA regarding mHealth regulation
However, Christy Foreman, Director of the Office of Device Evaluation at the FDA, said there was little cause for alarm. The agency will not label all smartphones or tablets that could possibly run a medical app as medical devices, nor does the FDA have any wish to limit innovation by imposing undue burdens.
“FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation, assuring appropriate patient protections,” she said.
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The FDA emphasised that calorie counters and fitness trackers posed little threat to patients, however apps that carried the same risk to patients as hospital-grade medical devices, such as those used to operate CT scanners from an iPad or program infusion pumps, should be regulated just as much as the equipment they link to.
“[The FDA has been] regulating medical device software for decades and medical device software on mobile platforms for more than ten years,” Foreman told the Committee. She continued, saying that adding certain mHealth apps to that catalogue of responsibilities would bring little detrimental change to the industry.
It’s the two-year delay in rulemaking that’s causing problems, argue many developers who have been waiting since July 21, 2011 to hear the fate of their business. Ben Chodor, CEO of Happtique, testified that some developers are stalling on potential products due to the uncertainty surrounding the FDA’s plans. Committee members speculated that taxes on medical apps might push programmers away from the next greatest health innovation and towards a more lucrative area, such as smartphone games or office software.
Foreman assured the committee that final guidance would be issued by the end of fiscal year 2013, bringing an end to the long wait, if not total satisfaction to those frustrated by government involvement in the first place. “We believe that focusing oversight on a narrow subset of mobile apps will encourage the development of new products while providing appropriate patient protections,” she concluded.
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.