Tag: FDA regulations

Matthew’s health care tidbits: Oh, the DEA makes me sigh….

Mar 7, 2023

Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

I have always thought that the dual role of the Drug Enforcement Agency (DEA) was an anachronism that severely hampers America’s complex relationship with pharmaceuticals. Congress deems some medicines legal and regulates them via the FDA, and deems others illegal and tells the DEA and other law enforcement agencies to attempt to control their supply. Leaving aside the basic futility of this task, somehow DEA was also given the task of regulating the prescribers of legal prescription (and non-prescription) drugs–in particular those around controlled substances.

This has led to decades of DEA-led persecution of doctors, patients and even convenience store clerks in the name of reducing the diversion of opiates and methamphetamines. Of course going after any of these folks is much easier and less risky than hunting a Mexican cartel or busting real criminals, so it’s easy to see why the DEA has taken that approach. Has it worked in reducing the supply of opiates? Maybe. Has it had any impact on the opiate crisis? Not really. Have a whole lot of patients been caught in the crossfire? Yup.

Now the DEA is moving onto the next phase–re-regulating the online prescribing of controlled substances that was liberalized at the start of the public health emergency in 2020. As you can imagine, their proposals are not exactly bursting with reason.

The DEA is essentially banning all controlled prescribing without a face to face visit first. This is despite the fact that the demand for those mental health medications increased dramatically during the pandemic as rates of depression and anxiety went up by a factor of three. While you can argue that in 2021 and 2022 some online services (notably Cerebral) may–and I stress may–have crossed the over-prescribing line for ADHD and other conditions, there’s no evidence that what happened is any worse than the in-person care that the DEA has been inadequately overseeing for decades. More importantly, those online services have already pulled out of those exact therapeutic markets the DEA is alarmed about. Who is left providing online ADHD care? Local clinicians and reputable services. And of course DEA knows full well, and is doing nothing about, the lack of access to mental health professionals that existed long before the increase in demand.

Is there any reason to suspect DEA will improve the quality of the system dealing with these medications? Highly doubtful. There are two current examples suggesting why not. First, due to the increased demand from the pandemic induced mental-health crisis and production problems at pharma company Teva, there’s a massive shortage of ADHD medication already. The DEA could help patients out here, but have declined to increase production quotas–sending millions of patients and their parents on a wild goose chase hunting down pharmacies with actual supply of Adderall and related meds.

Secondly, the DEA wants to also ban the the online prescribing of another drug , buprenorphine, which is used to help wean patients with substance use disorder off opiates and other substances. OK, so there’s a one month grace period here but essentially this is a short-sighted ban that will directly lead to patients going to the black market to acquire opiates, leading to more addiction and death.

My conclusion is that the DEA should be removed from its oversight of licensed clinicians and that role be given to FDA or HHS. At the least these proposed regulations should be abandoned and rolled back to what we have now. The only good news is that there is still time to comment on the regulations. I went and did so and I hope you will too. Patients have suffered enough already.

The Open Data Movement Runs Aground on FOURIER

Jan 19, 2023

BY ANISH KOKA

Reanalysis of a trial used to approve a commonly used injectable cholesterol-lowering drug confirms the original analysis by accident.

The open-data movement seeks to liberate the massive amount of data generated in running clinical trials from the grasp of the academic medical-pharmaceutical industrial complex that mostly runs the most important trials responsible for bringing novel therapeutics to market.

There are only a few elite academic trialist groups capable of running large trials and there’s ample reason to be suspicious about the nexus that has developed between academia and the pharmaceutical companies that shower them with cash to hopefully get a positive study result and pay off the pharmaceutical research investment manifold. The FDA is the major regulator of the whole process, but the expertise required for regulation means that the FDA is frequently comprised of ex-pharma employees or ex-academics.

The FDA & Me (or How to Explain Your Test Isn’t a Game)

Mar 6, 2015• 2

By CORI LATHAN

So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration (FDA).

Our app, DANA uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD).

For something so important, a serious investment of time and money for clearance may not sound extravagant, but few small companies can afford a two-year go-to-market delay, not to mention the significant investment and heartache that goes with it. And although the FDA has tried to facilitate regulation by providing guides like the Mobile Medical Applications Guidance Document and the Mobile Medical Applications website, the regulatory process remains confusing.

Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA:Continue reading…

Health IT: The Coming Regulation

Apr 14, 2014• 4

By Andy Oram

The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?

The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.

Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.

I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:

The suggestion that quality programs should start to look at electronic health records (p. 8). EHRs have been certified by various bodies, but usually just to check off boxes and declare that the systems comply with regulations–neither the quality of their user interfaces nor the quality of their implementations have been questioned. Reportedly, the FDA considered “safety and quality standards” for electronic health records in 2010 but couldn’t get them adopted. It also checks certain forms of clinical decision support, but only if they are built into a regulated device. The current HHS report refers back to aspirational documents such as a Health Information Technology Patient Safety Action & Surveillance Plan and a set of guidelines on the safety of EHRs.
A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.

Don’t imagine that the FDA is unused to regulating software. For quite some time they have instituted practices for the software used in some medical devices , and have tried to keep them up-to-date.

A waterfall-like process of risk assessment and testing called computer system validation has long been required for pharma and devices.

A Coming Storm: FDA Regulation of Mobile Medical Applications

Oct 24, 2012• 14

By Ryan Minarovich

I recently had the great fortune of attending Health 2.0 in San Francisco. The conference was abuzz with new medical technologies that are harnessing the power of innovation to solve healthcare problems including many new mobile medical application companies showcasing their potential. As I walked and talked around the exhibit floor, one thing caught my ear, or I should say one thing didn’t catch my ear. Among the chatter about these products, the concern about FDA regulation of this product segment, or even FDA regulation in general was noticeably absent. While many of the application developers are well aware of potential FDA involvement, most would be hard-pressed to outline the impact this would have on their companies and products.

Being labeled a medical device, which is the direction the FDA is leaning, could have a significant impact on business model organization, top-line revenue, and product deployment. For unprepared start-ups, FDA regulation could signal an end for their company. This is in stark contrast to well informed developers who are preparing themselves for the change and would most likely be able to leverage these regulations to their advantage.