MyFitnessPal and the State of Data Privacy in America

By JASON CHUNG

This week MyFitnessPal announced that it had suffered a massive security breach which exposed or compromised 150 million MyFitnessPal accounts. Data that is affected included usernames, email addresses and hashed passwords. Luckily for those affected, the company claims that the affected data did not include government-issued identifiers or payment card data.

In some good news for MyFitnessPal users, the stolen passwords were encrypted. However, Under Armour continues to be vague about which percentage of the stolen data was protected by bcrypt, a secure algorithm employing key stretching, and what used SHA-1, a legacy hashing algorithm no longer considered to be “any good”.

That such data breaches occur should no longer be a surprise to anyone particularly given other high-profiles breaches involving companies such as Equifax, Yahoo and Target. However, what is surprising in this case is that cybersecurity experts are beginning to commend Under Amour for their “prompt response to the data breach after its discovery and their public announcement alerting users to the danger”.

Such praise for simply engaging in what most consumers would consider obvious moral behavior may shock many Americans. After all, isn’t it intuitive and legally responsible of companies that suffer data breaches to engage in proactive disclosure?

But common sense and morality have long ceased to play a central role in many companies’ behavior, with market capitalization being king of all considerations in modern business. As noted by Tony Bradley in Forbes, the truth is that in such situations, “[i]t is not uncommon for companies to delay the inevitable by weeks or months”.

In fact, with the hodgepodge mess of data privacy and security breach notification laws in America, the strongest legal regime which mandates such disclosures is now a European one, the much-feared General Data Protection Regulation (GDPR) which goes into effect in May. That the strongest compelling force for American companies to disclose security breaches will emanate from Europe, through a law that is only relevant when users and data pass through that continent, is a damning indictment of the entire American data privacy and security regime.

In October, I noted to the U.S. Department of Health and Human Services that the federal landscape of data privacy and security is “a mess”. Currently, there is no clear controlling legislation in this domain, a patchwork of agencies fighting for regulatory relevancy and a system which dumps the onus of legislation and enforcement onto states which are ill-equipped to take on such a burden.

For instance, Section 1798.82 of the California Civil Code (where MyFitnessPal is headquartered) does require a person or business that conducts business in California or owns, licenses or maintains computerized personal information to notify the owner of the information, any relevant third parties and potentially the California Attorney General of a security breach. However, the duty to disclose and remedies for failure is naturally limited to California residents given the limited jurisdiction of the state.

Luckily for consumers, every state has security breach notification laws. However, due to the difference in legislative wording and interpretation, there is no consistency across the US with regard to key elements such as who must comply, definition of what constitutes “personal information” and even requirements for notice.

Looking federally, no answers are immediately apparent on the horizon even as proposed legislative action heats up. In the Senate, Democrat Bill Nelson is spearheading the proposed Data Security and Breach Notification Act and, in the House, Republican Representatives Leutkemeyer and Maloney have introduced the Data Acquisition and Technology Accountability and Security Act. But problems plague both bills.

The Republican bill will face a stiff test from states’ Attorneys-General who take issue with the bill’s preemption of all state data breach and security laws, particularly as it allows entities suffering breaches to determine whether to notify consumers of a breach based on their own judgment of whether there is “a reasonable risk that the breach of data security has resulted in identity theft, fraud, or economic loss to any consumer”.

For its part, the Democratic Senate bill currently looks unlikely to pass given the current composition of Congress as well as the fact that Nelson’s bill has already failed to pass once, in 2015.

Less than a month ago, I wrote about the need for a National Health Data Strategy. Incidents such as MyFitnessPal underscore that need even further today. The current framework for how we handle data – and increasingly commingle health data with other data – should highlight the need for a new regulatory and enforcement regime to create and maintain consistent standards and expectations for those collecting, storing, analyzing and trading in our data.

With Americans’ personal data being now a lucrative product, the way that we handle such a valuable product needs to be standardized and harmonized. Otherwise, we may continue living in a dystopia where we congratulate companies for doing the bare minimum in handling our data.

Jason Chung is the Law & Technology Editor at The Health Care Blog. He also writes on the intersection of health, technology and sports as the senior researcher and attorney at NYU Sports and Society, a think tank dedicated to the study of sports and social issues. He tweets @ChungSports.

from THCB https://ift.tt/2uzb9jP

HHS Conscience Rule Would Grant Providers Sweeping Rights to Deny Care

By DAVID INTROCASO

In late January the Trump administration proposed a Department of Health and Human Services’ (DHHS) regulation that would legally protect any health care worker who refuses to provide care directly or indirectly to any individual by claiming a religious, moral or conscientious objection. While the federal government has for decades protected freedoms of conscience and religious exercise, the proposed would vastly expand these protections. No longer would these protections be applied to a very limited number of medical procedures. Think: abortion. Now, for example, a pediatrician could to provide care for a lesbian couple’s newborn or an emergency room nurse could refuse to provide a terminally ill patient palliative sedation.

Criticism of the proposed rule was immediate. Opponents contend if finalized the proposed would allow providers to ignore a patient’s medical needs including emergency needs that in some instances cause the patient further harm. It would undermine a healthcare entity’s effectiveness and patient safety responsibilities and would legally allow a provider to violate both their professional code of ethics and the patient’s civil and human rights. Critics argue the rule constitutes, in sum, an insidious form of bigotry. It would weaponize discrimination particularly against LGBTQs. It would, for example, roll back the Obama administration’s interpretation of the Affordable Care Act’s (ACA) anti-sex discrimination provision that protected gender identity. These, not insubstantial, criticisms aside there appears to have been little discussion of the proposed’s underlying rationale. What is the Christian theological basis, if any, for legally protecting religious exercise in denying health care?


The Proposed Briefly Summarized

The proposed rule published January 26 and titled, “Protecting Statutory Conscience Rights in Health Care, Delegations of Authority,” notes the federal government has since the 1970s through various legislative amendments including Frank Church, Coats-Snowe, Weldon and others, allowed health care providers freedoms of conscience and religious exercise. Initially, these religious belief or moral conviction protections were related to performing or assisting in a certain, few medical procedures, moreover abortion and sterilization. Over the years, these protections have been somewhat expanded to include other medical or medically-related services. For example, the 2010 Affordable Car Act included a provision protecting clinicians with religious objection to participating in assisted suicide.

The current proposed rule would, again, substantially expand these protections. Who would be potentially protected and under what health program activity is defined at length in the proposed. The health care entity or provider is broadly defined to include all health care personnel including those in training, in a hospital, a laboratory, a health insurance plan, a plan sponsor, components of a state or local government and/or any other kind of health care organization. Anyone of these individuals or entities can object to, the proposed states, “any health-related services, health service programs and research activities, health-related insurance coverage, health studies, or any other service related to health or wellness whether directly, through payments, grants, contracts or other instruments, through insurance, or otherwise.” The proposed also protects health care personnel from providing a referral. This provision is as well broadly defined. A provider could decline to provide any referral information by any method and decline to provide any information about those who would in turn provide a referral.

Beyond redefining how these protections are applied the proposed makes clear the DHHS Secretary is delegating to the Department’s Office of Civil Rights (OCR) full enforcement authority such that objections based on conscience or religious objection are protected in the same way the OCR ensures compliance regarding civil rights requirements. The proposed would affect as many as 750,000 hospitals and physician offices.

What Does Christian Doctrine Say?

At the National Cathedral, the Cathedral of the Episcopal Church, resides the Missioner for Evangelism and Community Engagement for the Episcopal Diocese of Washington, D.C., the Reverend Patricia Lyons. As her title suggests Reverend Lyons’ primary responsibility is to articulate and apply Episcopal or Anglican faith in the public square or serve, as Episcopal faith dictates, the common good in partnering to advance social justice. During a somewhat lengthy conversation with her this past March 26th, we discussed at some length how the proposed rule constitutes a perverse interpretation of Christian theology.

The only aspect of the proposed consistent with Christian theology is that it recognizes an individual’s right to follow or obey their conscience or their religious or moral beliefs. Thousands of years of religious teaching supports this view. Each of us has an authentic, unique self. Absent that, who are we? As Hillel said, if I am not for myself, who will be for me. It’s considered, as Reverend Lyons said, one’s obligation, one’s sacred duty since through one’s conscience we hear the voice of God. That said, both withholding any health-related service based on one’s conscience or religious beliefs and having it legally protected is problematic for several theological reasons.

If following our conscience is our only obligation, if it is absolutized or turned into an idol as Reverend Lyons characterized, it would turn religious and moral life into an individual affair. We would as individuals be able to, as she observed, turn against the world. Such allowance would trump (no pun) our obligations to one another. Christian theology teaches that we are constituted as individuals precisely by our relationship with others. It is only because of our relationships with one another do we become fully human. I cannot be me without you. Since Christian theology is intrinsically communal we have reciprocal obligations to one another. This means all social goods be shared equally or communally. Christian theology teaches no one individual enjoys absolute exclusive rights and that God did not intend to distribute the necessities of life, least of which healthcare, unequally.

That the government would protect an individual’s right of conscience and religious objection, that the individual would suffer no legal consequence exercising such right, is also a perversion of Christian teaching. Christian theology, as enumerated for example in several Catholic encyclicals, teaches the principle of subsidiary. That is render unto Caesar what is Caesar’s. While again, Christian theologians would support an individuals conscience rights they do not believe exercising such should be without consequence. As Reverend Lyons recognized, the government’s purpose is largely to deliver justice. Since medical care, for example and again relieving the suffering of a newborn or the terminally ill, is not illegal, the government’s has a duty, an obligation, to deliver justice. For the government to ignore in turn its obligations obviously undercuts the rule of law. It is a crime itself. It leads, Reverend Lyons argued, to a radical re-conception of government and is only workable if we intend to move from democracy to theocracy. Do we want the state, she asked, to protect people from the consequence of the law? Do we want to move in the direction of effectively establishing one religion over another?

The proposed presents several other theological-based problems. Among others, that the OCR will legally protect health care workers exercising conscience or religious objection would mean their employer would have no recourse. That is a provider could violate their professional code of ethics. As Reverend Lyons explained the Episcopal Church teaches professional codes are based on the conception that professional accomplishment is ultimately God’s gift. God granted the health care provider certain intellectual capabilities and other gifts. Therefore, since the individual does not own their profession, all individuals within the profession are subject to a code of ethics. That would mean a health care provider is required to participate indiscriminately in the enabling the realization of what that profession offers others. As the American Academy of Family Physicians wrote in its March 20th letter in response to the proposed, “There is a distinct difference between declining to participate in a procedure versus denying access to care to an individual patient. The former is a protected right, the latter is an unacceptable shirking of our basic responsibility to care for our patients and contrary to the key underpinnings of the Code of Medical Ethics.”

As written the proposed would have to allow a person to exercise any religious belief Christian or otherwise and any exercise any conscience choice, say an atheist’s conscience choice. Would then an atheist provider be legally protected from treating a God-fearing patient? The proposed turns the long-established possessive individualism of the modern market economy criticism on its head. Instead of conscience and religious exercise moderating the excesses of capitalism, such exercise would reinforce the market definition of people as commodities. (Christian theology teaches the purpose of life is not to consume or accumulate but to do justice.) The proposed would also prove to further exacerbate already daunting health care disparities. For example, polling data shows transgender individuals already frequently have negative healthcare experiences, are denied care, or avoid seeking care for fear of being mistreated. The proposed in not good news for them.

If anything the proposed reminds us of how woefully short we fall in living up to Christian teaching. Social goods, particularly health care, are considered communal. In this sense theology and economy are correlative. To deny someone, anyone, the gift of healing is in a word unfaithful. It denies God’s interest that all of us can find an abundant life. It is also uncharitable. Faith without charity we know from St. Paul, is non-salvific. The proposed is not what Christian theology teaches. It, instead, eclipses these teachings.

from THCB https://ift.tt/2Gl994h

How the VA Colon Cancer Screening Program Fails African-American Males

By BAILEY FITZGERALD, MD
“It’s a terrible way to die” The oncology fellow told me bluntly as we walked to the room. “There is nothing okay about this.”
Knocking on the open door, we entered his room. The blinds were raised to reveal a stunning view of the area surrounding the VA hospital, and light poured in.

Our patient reclined in bed, his eyes closed although he was not asleep. He opened his eyes at the sound of our entrance, and the eyes seemed to bulge, too large for his shrunken face with wasted muscles. A plastic tube, taped to the bridge of his nose, entered his nostril and disappeared. The other end of the tubing led to a canister filled with dark green liquid that had been suctioned from his gastrointestinal tract. Despite this invasion, his stomach remained distended, protuberant compared with his otherwise frail frame.
The man had an aggressive colon cancer. The tumor in his colon had grown so large that the hollow of his bowel had closed off, allowing no food to pass through. With nowhere else to go, the contents of his bowel backed up, puffing out his stomach and causing terrible nausea and vomiting. Even worse, the tumor invaded outwards too, anchoring tendrils into the surrounding tissue so that there was no longer any hope of removing the tumor surgically. “Palliative” chemotherapy to try to shrink the tumor would be offered, but it had no chance of curing his disease. The oncologist’s note summarized the situation: “Prognosis is extremely poor.”

 It was a good learning case, a late presentation of a disease increasingly diagnosed at early stages by screening colonoscopies. This patient had not undergone screening, which might have diagnosed the cancer while there was still time for a cure. As an African American, this patient was more likely to develop this cancer than Caucasian patients his age.

The VA hospital system is a model of preventative care, and such late presentations are rare. March is Colon Cancer Awareness Month, and at the VA hospital where I work, announcements flash on computer screensavers, reminding doctors to talk to patients about screening. Compliance rates with colon cancer screening have been shown to be 82% within the VA system, compared with around 60% outside.[i]
But we’re not screening everyone who is at risk. The VA’s system of clinical reminders leaves one group of patients without adequate screening, despite adjustments in guidelines. African Americans are more vulnerable to colon cancers, with a 25% higher risk and a 50% higher mortality rate.[ii]  The mechanism of this disparity is poorly understood, and is likely from a combination of genetic and social factors, including lower rates of screening. In an effort to combat this disparity, U.S. Multi-Society Task Force of Colorectal Cancer (MSTF) revised their guidelines to recommend colon cancer screening for African American patients starting at age 45, rather than age 50, which is still recommended for everyone else based on the United State Preventative Services Task Force (USPSTF) guideline last updated in 2016. [iii] [iv]
Currently the VA’s National Center for Health Promotion and Disease Prevention fails to acknowledge this risk[v]. The website lists screening recommendations in a color-coded grid: green is recommended, yellow acknowledges that the evidence is mixed, and depends on individual patient factors. For ages 50-75, the box is green. For patients 76-85 the box is yellow, despite the USPSTF’s caution that, “The rate of serious adverse events from colorectal cancer screening increases with age.” For ages 45-50, there is a red box: not recommended, without acknowledgement of the most recent guidelines. This policy has practical effects. Practicing primary care at the VA, I only receive automatic reminders to consider screening my patients above age 50, even if they are African American and might want to consider earlier screening.
To be sure, screening tests are only effective if they are offered and if patients adhere to recommendations. The patient I described was offered a colonoscopy and refused. And the harms of over screening are real, including complications from screening procedures or over-treatment of incidental findings. But in an area where the consequences for our patients could be dire, and the disparities are great, the Veteran’s Health Administration has a duty to continue to lead the nation in providing the best possible care. Colon Cancer awareness month is coming to an end; before it’s over let’s change the box to yellow, and encourage VA doctors to discuss the most up-to-date guidelines with their patients.

from THCB https://ift.tt/2GVQyJ5

The Myth That Refuses to Die: All Health Care is Local

In 1980, industry healthcare planners imagined a system where the centerpiece was a hospital in every community and a complement of physicians. Demand forecasting was fairly straightforward: based on the population’s growth and age, the need was 4 beds per thousand and 140 docs per 100,000, give or take a few.

In 1996, the Dartmouth Center for the Evaluative Clinical Sciences published the Dartmouth Atlas on Health Care quantifying variability in the intensity of services provided Medicare enrollees in each U.S. zip code. They defined 306 hospital referral regions (HRRs) that remain today as the basis for regulation of our healthcare system.

In the same timeframe (1980-2000), the ratio of doctors per 100,000 doubled as the number of medical schools increased from 75 to 126 leading health planners (Graduate Medical Education National Advisory Council) to predict a surplus of 70,000. Meanwhile, demand for hospital beds edged down slightly to 3.5/1000—the result of managed care efforts in certain parts of the country.

Today, we operate 2.4 beds per thousand and have 265 physicians per 100,000. But the bigger story is the widespread variability in the volume, costs and quality of care across our communities.  Across the 306 HRRs, bed supply ranges almost 250%; physician supply even more and costs as much as 400%.

For almost 40 years, we’ve operated the U.S. health system based on an underlying assumption that all healthcare is local. We’ve presumed that except in rare circumstances, patients stayed home for the care they need. But that’s changing.

Three trends are converging that are changing how we think of the markets we serve:

Virtual care: Goldman Sachs forecasts virtual care will be a $20 billion industry by 2020 as employers and insurers adopt lower cost options to local medicine. Investor-funded companies (American Well, Teladoc, 2nd.MD, Carena, Health Integrated, MD Live, et al) offer distance medicine that is convenient and less costly. 78% of consumers say they would be receptive to receiving care virtually (Carenet Healthcare Services) though only 14% of hospitals offer digital tools and only 23% offer telemedicine (Kaufman Hall). And funding for digital health is robust: per RockHealth, start-ups have attracted $18 billion in the last four years, with most applications targeting mechanisms whereby consumers can make better choices about the care they receive, where, from whom and at what cost.

Destination Hubs: Historically, individuals left their community when facing a complex diagnosis based on a referral from a trusted local clinician. For cancer, Hutchinson, Dana Farber, Memorial Sloan Kettering, Mayo, MD Anderson, Moffit and others were prominent. For hearts, Cleveland Clinic, New York Presbyterian, Mayo, Mass General, Duke, Northwestern, Brigham and Women’s and others attracted referrals. Most of these set-up referral management programs to accommodate out of town patients, offering lodging and other forms of assistance. But destination hubs have expanded beyond those that cater to physician referrals. Each of these is a business model that makes a big bet that consumers will leave their community for care elsewhere:

Founded in 1988, Cancer Treatment Centers of America (CTSA) operates inpatient and outpatient facilities in 5 markets. Its national ads promote its integrative clinical model and patient-friendly approach to diagnosing and treating the full continuum of cancers. On its website, patient satisfaction scores for each patient cohort are reported with scores averaging above 95%.

Founded in 2005, Laser Spine Institute operates surgery centers in 7 markets and advertises nationally. It offers a free MRI and requires candidates for their minimally invasive procedures to stay within 15 miles of their surgery center one day after the procedure for post-op follow-up. Per its website, the company has performed 75,000 procedures: 60% for patients who live outside its markets.

Large employers like Boeing, Wal-Mart, Lowe’s, Whole Foods are contracting directly with hospitals out of their local markets. Though only 3% of employers contract directly today, the National Business Group on Health estimates activity will increase as health costs escalate in coming years.

And medical tourism remains a factor: According to Patients beyond Borders, 1.4 million U.S. adults traveled outside the U.S. for medical care last year. The Joint Commission International accredits 458 hospitals off-shore that perform elective surgical procedures as 30% of the

So, destination hubs are no longer limited to tertiary care providers in urban settings.

Affordability: One in five Americans under the age of 65 say they are having problems paying their medical bills and 2 million will declare bankruptcy due to medical debt this year (Nerd Wallet). As prices charged by U.S. providers. Reported by the Federal Reserve last November, household debt hit an all-time high last year increasing 16% since the summer of 2013. Student loan, medical and mortgage debt are the culprits. As households face higher deductibles, affordable options will be on their radar. Out-of-market healthcare services offered at a lower price by a reputable provider will be attractive. And the entry of Amazon-JPMorgan-Berkshire Hathaway into the fray of employer benefits and health cost containment promises to spark increased consideration of new models and strategies.

The bottom line is this: healthcare is no longer about competition between insurers, physicians and hospitals operating in a relatively confined hospital referral region. It’s about health facilities and services offered by parties that bet local consumers will respond favorably to their pitches.

The reality is that consumers are finding alternatives to local care: some to obtain services they can’t get at home and many for care they think better, cheaper or easier to access elsewhere.

For the least fortunate in our communities, staying at home for care is reality. For others, out of town options are expanding.

Strategies that presume all healthcare is local are bound to the same fate as Borders, Blockbuster and 10,000 other retailers who’ve ceased operations in the past decade as their markets changed (National Retail Federation). They recognized the retail apocalypse too late to respond.

So, at best, some healthcare is local, but not all.

Paul

from THCB https://ift.tt/2GiEPTD

What Parents of Athletes Should Know About Injuries and Abuse

I’m not a parent. But I was once a gymnast. Now I teach at a medical school. As far as my own injuries, I consider myself lucky; I can walk through airport security without setting off any metal detectors. But I certainly have had my fair share of visits to the emergency department, the orthopedist, the chiropractor, and the physical therapist – as an adult and as a child, at times without a parent present.

We heard so many powerful statements from young women at Larry Nassar’s sentencing hearings. As I read and listened to these women confront their abuser, I was empowered by statements like those of Kyle Stevens, who said: “…little girls don’t stay little forever. They grow into strong women that return to destroy your world.”

But I wondered if parents of male athletes were paying as much attention to the Nassar story as were the parents of young girls. Now that the first male gymnast has come forward to accuse Nassar of sexual abuse perhaps they will.

As a health educator-turned-bioethicist who studies physician sexual abuse of patients, I have some practical advice for parents.

First, if your child is at a competitive level, talk to him about injuries now – before they happen. Tell him how important it is that he is honest with you about his injuries. Emphasize that his health is more important than anything else. Injuries will occur at inconvenient times – after plane tickets have been purchased for an away competition, after tens of thousands of dollars of been spent on training, before the offer of a college scholarship is finalized. Let him know that you will never be angry with him, that he will never be in trouble for being hurt. Your child has worked tirelessly. She is a perfectionist. She is an overachiever. She is a risk taker. She is a badass. She may not have been alive when Kerri Strug hobbled down the vault runway on an injured ankle at the 1996 Olympics, but she’s seen the video. She knows how much you have sacrificed – whether or not you have ever pointed this out. And whether it’s because she doesn’t want to disappoint you or her coaches, or because she doesn’t want to miss an opportunity, voices in her head are telling her to say that it doesn’t really hurt that much. National team members speaking out against Nassar mentioned instances where they specially asked to receive treatment in private, because they were worried that if their coaches or parents knew, they wouldn’t be allowed to compete.  In order to truly respect his victims and prevent future abuses, we cannot ignore that as a physician, Nassar offered much that these young athletes needed – relief from physical pain, emotional support in an extremely stressful environment, and an ally when they were being pushed to train or compete while injured. Make sure your child knows that you are her ally.

Second, accept but that injuries are inevitable. Prepare to decide whether or not your child will be allowed to train and/or compete when injured. You will make these decisions in consultation with coaches and physicians or athletic trainers, but ultimately you as a parent are responsible for your child’s safety and welfare. Nassar himself said this during a 2013 podcast.

Third, there is a simple, practical way to prevent abuse by a physician or trainer. Nassar initially denied any misconduct, and then changed his story to claim that vaginal penetration was “standard treatment.”  If your child requires ongoing treatment for an injury, and especially if you will not be present for every session, ask the treating physician or trainer, in front of your child, to describe in detail what that treatment will involve. Then, say to the provider, in front of your child: “If you decide to do something different, or someone else will be involved in treating my child, please tell me first.” And to your child, in front of the provider, say: “If the treatment you are receiving seems different from what’s being discussed here, ask to stop immediately and tell me.”

This suggestion may be perceived as putting responsibility for preventing abuse on vulnerable victims. But there’s no harm in educating all patients about what to expect at the doctor’s office. This improves the patient experience. Institutions –USA Gymnastics, the International Olympic Committee, and Michigan State University – and administrators and coaches working at those institutions are also to blame for ignoring complaints about Nassar and perpetuating the cultures that allowed him to abuse so many young athletes for so long. The health care system must also take greater action to prevent physician misconduct. But institutions are slow to change, and bad apples are difficult to screen out. Talking to your kids more can’t hurt.

Emily E. Anderson, PhD, MPH, is associate professor of bioethics at Stritch School of Medicine, Loyola University Chicago and a Public Voices Fellow at the OpEd Project.

 

from THCB https://ift.tt/2pMsReX

Making Progress Toward Healthier Pharma Markets

Pharmaceuticals play a major role in today’s population health era – they can prevent and cure disease, improve or maintain wellness and slow progression of existing conditions. Yet, their promise can also be a curse if high prices limit patient access and bankrupt the healthcare providers and insurers bearing significant financial risk for patient care.

The proactive new leadership at the FDA is promoting competitive markets by combatting the abuse of well-intentioned programs and market share monopolies. Commissioner Scott Gottlieb has ramped up the FDA’s efforts to prevent drug manufacturers from “gaming the system” in a number of ways.

Accelerating generic approvals and creating transparency to stimulate competition

For the first time, the FDA made publicly available a list of off-patent, off-exclusivity branded drugs without generic competition. Using the list, Premier immediately identified a number of critical drugs for patient care and has been working with manufacturers to participate in the FDA’s new expedited review process. Additionally, Congress recently enacted legislation creating an expedited review process for generic drug applications when there are fewer than three manufacturers in the market for a given drug product. We strongly support and helped to champion these efforts, and are hopeful that the FDA will use this new authority to foster competition and curb price spikes and shortages in generic drugs where only a few players dominate.

Reducing duplicate or redundant review processes

We anticipate the FDA will soon release key documents to streamline the Abbreviated New Drug Application process, which will help eliminate unnecessary, duplicative procedures and greatly increase efficiency without compromising standards.

Curbing abuse of Risk Evaluation and Mitigation Strategy (REMS)

Commissioner Gottlieb has strong words for abusers of the REMs program, stating, “some manufacturers are… using the law as a way to delay the ability of generic firms to purchase the doses of a branded drug that they need to run their studies and get to market.” The FDA has been taking important steps to help prevent exploitation of the loophole by releasing draft guidance to stem drug manufacturers’ abuse of REMS.

We also call on Congress to level the playing field for new market entrants that foster competition in order to drive down inflated drug prices.

Policy change is urgently needed to close loopholes and get competitive entrants into the market faster. The Fair Access for Safe and Timely (FAST) Generics Act and the Creating, Restoring Equal Access to Equivalent Samples (CREATES) and Preserve Access to Affordable Generics Act are clear, bipartisan solutions to curb abusive, anticompetitive business practices that are driving up unsustainable spending within healthcare and impede patient access to generic and biosimilar medicines.

We know competition works. Our aggregated group purchasing power alone puts manufacturers through a head-to-head bidding process that brings results. Premier’s drug portfolio prices have held constant at just 4.55 percent per year, well below the inflation rate of 10 percent over the same time period on all drugs with no contractual terms.

While the FDA has made significant progress toward adopting policies that push more competition, there still is a long way to go before these policies have a real, meaningful upstream effect. From reducing and prioritizing backlogged approvals, accelerating entrance of biosimilars into the market and facilitating increased competition around branded drugs, stakeholders from across healthcare, including Premier, are ready and willing to work with the FDA to bring in more manufacturers into the fray and foster healthier markets for pharmaceuticals.

Calling out the abuses is important, but we badly need action by both FDA and Congress.

Michael J. Alkire is chief operating officer of Premier Inc., a healthcare improvement company.

from THCB https://ift.tt/2IU6XhH