Pharmaco-Epi Community Responds to New Study re: Cost of Cancer Drugs
Posted in News on 9.15.2017
Pin pointing the dollar amount that it actually costs to bring a drug to market is a tricky business. Until recently, the most widely accepted estimate has come from Tufts Center for the Study of Drug Development, at $2.7 billion per drug.
Yet a new study published in JAMA places that number much lower, a median cost of $757million per drug. The JAMA study evaluated 10 cancer drugs, which are among the most expensive drugs, making their findings even more surprising.
The paper was received with both praise and criticism. Dr. Aaron Kesselheim, a faculty member of Brigham and Women’s Hospital’s Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) described the study as “thoughtful and rigorous”.
Representatives of the biotech industry, however, took issue with the way calculations were made—specifically, that they did not take into account the cost of many drugs that never make it to market.
Dr. Jerry Avorn, Alosa Health founder and Director at DoPE, commented that study is sure feed the ongoing debate over cancer drug prices, elaborating, “We are getting into areas that are almost unimaginable economically.” Read the full article here.
TOPCARE Intervention Shows Promise For Opioid Prescription Monitoring
Posted in Publications on 7.28.2017
A multicomponent intervention including academic detailing improved prescription opioid monitoring compared with electronic decision tools alone in a randomized trial of 4 urban safety-net primary care practices.
JAMA Intern Med. Published online July 17, 2017. doi:10.1001/jamainternmed.2017.2468
Prescription opioid misuse is a leading public health problem and likely contributes to overdoses. The evidence base supporting interventions to change clinical practice at the level of primary care physicians with respect to opioid prescribing is limited. For example, the effect of non-controlled interventions may be difficult to interpret in the setting of local, state and national level initiatives to reduce inappropriate opioid prescribing.
Lead investigator Jane Liebschutz and others from the Section of General Internal Medicine at Boston Medical Center conducted a cluster-randomized trial of 53 primary care providers and 985 of their patients categorized as long-term opioid users within 4 safety net clinics. Patients had a mean age of 55 and 62% had a history of a mental health diagnosis. 45% were insured by Medicaid. Over sixty percent of patients were using between 0 to 50mg of morphine equivalent doses prior to the start of the intervention. This dose is generally considered to be associated with a lower risk of drug overdose.
Opioid Intervention Methods
The trial was designed to test the efficacy of a multicomponent intervention called TOPCARE that included 1-on-1 academic detailing, nurse care management, an electronic registry and electronic decision tools. Control PCPs received the electronic decision tool only. The detailing component was a single session between one of the study coauthors (considered opioid prescribing experts) and the PCP. Topics discussed included: principles of safe opioid prescribing, monitoring, registry reports, details on patient monitoring and risk and challenging patient cases. The nurse care manager was a credentialed nurse who performed risk assessments, prepared prescriptions for PCPs, collected urine drug tests, pill counts, and checked the prescription drug monitoring program on behalf of PCPs. The web-based registry allowed data to be imported from the electronic health record and produced reports used to direct work flow. Furthermore, the registry provided feedback to the program, for example, by allowing study staff to see a PCP’s percentage of patients with an opioid use agreement. Finally, the decision tool included tools for assessment of opioid risk and interactive tools to assist with interpretation of urine drug testing results (a challenging clinical topic).
Study investigators found that the intervention improved the rate of adherence to recent opioid treatment guidelines. Specifically, at 12 months, patients randomized to the intervention were more likely to have a opioid-use agreement (OR 11.9) and have undergone at least 1 urine drug screen (OR 3.0). Unfortunately, the intervention did not reduce the probability of a proxy for opioid misuse: early refills, defined as a prescription refill for an opioid given more than 3 days before the next expected refill date. In exploratory analysis, they found that intervention patients had lower total morphine equivalent doses (6.8mg lower than controls, p<.001).
In conclusion, this study found that a multicomponent intervention including academic detailing improved prescription opioid monitoring compared with electronic decision tools alone in a randomized trial of 4 urban safety-net primary care practices.
With Drug Resistance, Prevention and Early Detection is Key
Posted in News on 7.13.2017
A news release from the World Health Organization (WHO) stated that gonorrhea bacteria are evolving in a way that makes the infection much harder to treat. Gonorrhea is a sexually transmitted infection (STI) that is generally curable with antibiotics. However, new data from various countries around the globe suggest that existing antibiotics are no longer sufficient in some cases as bacteria evolve to resist the known treatments.
While researchers are hard at work developing new drugs, prevention will be an essential component of public health strategy aimed at gonnorrhea in the meantime. As with any STI, education and communication around safer sex practices as well as the ability to recognize symtpoms and seek care can reduce the likelihood of spreading among sexual partners.
Among the innovative strategies adopted by local and regional health departments to address the spread of STIs is expedited partner therapy (EPT). Contact Alosa Health or check out our modules pages to learn more.
Post Editorial Reflects on Progress in HIV/AIDs Treatment and Prevention
Posted in News on 7.12.2017
The Washington DC Department of Health HIV/AIDS, Hepatitis, STD, and TB Administration (HAHSTA) recently published its Annual Epidemiology & Surveillance Report with good news, as noted by the editorial staff of the Washington Post. The report shows substantial progress being made in the D.C. area with respect to the number of newly diagnosed HIV cases as well as the number of people living with HIV.
For instance, the number of new cases of HIV diagnosed each year has gone down steadily since 2012, marking a 46.9% decline over the 5-year period of 2012-2016. The number of people living with HIV has held steady, but viewed as a proportion of total population and given the improved prognosis for individuals with HIV this data is encouraging.
D.C. is notable for the wide range of activities undertaken to address the issue. These include “increased testing and awareness campaigns, condom distributions, increased use of preventive medication … and a needle exchange program”.
Though not called out by name, we at Alosa Health know that academic detailing is included in at least two of the categories mentioned above— awareness campaigns (i.e., EPT) and increased use of preventive medication (i.e., PrEP).
Clinical Advisor Wins AGS Award
Posted in Updates on 7.11.2017
Alosa Health Clinical Advisor Dr. Dae Kim was recently presented with the prestigious Junior Investigator of the Year Award by the American Geriatric Society (AGS). This award is given annually to an outstanding junior investigator who is committed to a career in aging research. Dr. Kim’s research focuses on studying outcomes of drug therapy and cardiac surgical procedures in older adults. He also contributed his expertise in aging to Alosa Health’s Elder Abuse and Dementia module.
We at Alosa wish Dr. Kim a sincere congratulations on this achievement!
Alosa Exec Interviewed on Nightly News
Posted in Updates on 7.1.2017
Alosa Health Executive Director Paul Fanikos was recently featured on a news segment airing on NECN regional news network. Paul spoke with Brian Shactman about the opioid crisis in the state of Massachusetts, and in particular what can be done to mitigate harm related to opioid prescribing. He explained why academic detailing is an effective means of reducing opioid prescribing while giving providers other tools to manage pain in patients. We are so proud to raise public awareness of academic detailing and grateful to Paul for representing us on the show!
Want to hear more? Watch the segment here.
Baystate Health Opioid Overdose Program Initiated
Posted in Updates on 6.22.2017
A team of researchers at Baystate Health led by principle investigators Dr. Peter Friedmann and Dr. Josiah D. Rich have contracted with Alosa Health to implement a study testing academic detailing as a means to increase naloxone and buprenorphine prescribing in HIV treatment settings. Impetus for this study comes from previous research demonstrating high rates of opioid overdose among people living with HIV. Baystate researchers hypothesize that HIV physicians, given proper training, might be willing to integrate naloxone prescribing into their practice to prevent overdose death among patients.
Alosa Health is thrilled to work in tandem with this group to help execute the academic detailing component of the study.
PACE Introduces Elder Abuse Module
Posted in Updates on 6.22.2017
Alosa Health recently introduced an Elder Abuse/ Dementia module through Pennsylvania’s PACE program. This module focuses on caring for vulnerable elders by addressing elder abuse, managing dementia, and supporting caregivers. In keeping with our commitment to disseminating evidence-based information, this module contains guidelines on screening for both abuse and/or cognitive impairment as well as information on when it may or may not be appropriate to use cholinesterase inhibitors and other drugs in the treatment of dementia.
Academic detailers in Pennsylvania have already completed 250 visits to date, with feedback from providers describing the information they received as “relevant” and “very useful”.
Alosa Program Makes National News
Posted in Updates on 6.15.2017
Alosa Health’s successful work promoting safe opioid prescibing practices in Pennsylvania has captured the attention of several national news outlets researching stories on the opioid crisis. One of these, the Associated Press, recently contacted Alosa Health to see if they could send a reporter all the way to Monroeville, PA to shadow clinical educator Melissa Jones during her meetings with physicians in the field. Naturally we jumped at the chance to spread the word about academic detailing. After all, we love an opportunity to teach others about how academic detailing works and why.
Curious about how the visit went? Read the full story here.
Alosa Partner Recognized for Exceptional Work
Posted in Updates on 5.23.2017
Congratulations to our longstanding partner the Pennsylvania Department of Aging and to Director Denise Getgen on being recognized for demonstrating exemplary leadership and strong commitment to protecting the health and wellbeing of elderly citizens... a well-deserved honor. Denise is one of a small group of state employees to receive the Governor’s Award of Excellence. We are grateful for the opportunity work alongside you, and look forward to continuing our work together.
What Assault on FDA Authority Means for Public Health
Posted in News on 5.11.2017
In a piece recently published in The American Prospect, Alosa Health founder Dr. Jerry Avorn discusses regulatory trends around drug manufacturing and marketing as well as their consequences, making the case that diminishing FDA authority could have harmful effects on patients.
Specifically, he cites the 21st Century Cure Act, which nudges the FDA away from controlled clinical trials and toward measures of evaluation that are narrower in scope, such as whether a drug has an impact on a particular biomarker. Without information gleaned from controlled clinical trials, drugs may come to market absent proof of a net benefit to patients.
In addition to its primary responsibility of evaluating drug efficacy, the FDA also has a responsibility to evaluate marketing claims made by drug manufacturers. Now it appears that authority is also weakening, with the effect that pharmaceutical companies have more leeway in the statements that they can make to consumers. During a 2011 case, for instance, a pharmaceutical sales rep successfully invoked the First Amendment to defend statements that he made promoting a drug for use in clinical situations for which it was not approved.
As Dr. Avorn cautions, the two developments above combined with a president and FDA Commissioner intent on de-regulation as a matter of policy hearken back to a much earlier era in history when medical treatments were not regulated and public health suffered, prompting the government to step in. Read the full article here.
Alosa CEO Tapped for Church Crusade Against Opioids
Posted in Updates on 5.10.2017
Alosa Health CEO Cheryl Bartlett was asked to speak to students at Holy Cross Greek Orthodox School of Theology in Worchester, MA as part of an ongoing effort to dispel myths around opioid addiction and reduce stigma. The Saint Spyridon Greek Orthodox Church has made caring for community members with opioid addiction a top priority by embracing a doctrine of caring without judgement. Members of the clergy see themselves as frontline responders to the opioid crisis; as such, they believe that understanding families struggling with addiction is an essential part of their training.
The church's approach is so innovative that the story (and Cheryl’s appearance!) was picked up by Channel 5 news. Take a look at the clip here.
FDA Review Process Speedier than European Counterpart
Posted in News on 4.6.2017
The FDA has been getting flack from the U.S. President as well as the president’s nominee to lead the agency, Dr. Scott Gottlieb, on account of their approvals process, which has been characterized as “slow and burdensome”.
Yet, a recent study published in the New England Journal of Medicine (NEJM) revealed that the FDA approved drugs, more quickly than its European counterpart, the European Medicines Agency (EMA), during the 4-year study period. The median review time of the FDA was 306 days, while the median review time for the EMA was 383 days.
It appears that the relative speed of the FDA compared with the EMA may be attributed to certain sub-groups of drugs. While the FDA was speedier at approving drugs for cancer and blood diseases, as well as “orphan drugs” for rare conditions, there was no difference in speed between the two agencies for other drug approvals.
The information from this study is particularly relevant as lawmakers wrestle with the question of whether to maintain or discard certain FDA regulatory processes. Read the full article here.
Proposed NIH Cuts Would Inhibit Medical Research
Posted in News on 3.30.2017
The current iteration of the federal budget proposed by the U.S. President would cut $1.2 billion to the National Institutes of Heath (NIH), though the budget needs to be approved in both houses of Congress before it can go into effect and thus modifications are possible.
The cuts target research grant funding, which would substantially reduce the capacity of NIH to fulfill its primary objective of conducting biomedical research. In the past, NIH research has led to breakthroughs in our understanding of diseases such as cancer, diabetes, and Alzheimer’s as well as new technologies that map the human brain, sequence genes, and show us images of the human heart.
Advocates of science and research have criticized the proposed budget cuts to the NIH, stating that it would be “throwing progress out the window” and endanger the health of Americans. Read the full article here.
New Faces: Linda Cordell and Dr. XinQi Dong
Posted in Updates on 3.28.2017
We are excited to announce that Linda Cordell has joined Alosa Health as an academic detailer in Shelby County, TN. She will be detailing on the use of PrEP, or pre-exposure prophylaxis, as an HIV prevention strategy for high-risk individuals. Linda brings 15 years of experience in clinical nursing to this role as well as extensive knowledge of the region’s healthcare landscape. She has cultivated relationships with local providers based on mutual respect and earned trust over years of working as a clinical consultant in the pharmaceutical industry. Welcome to the team, Linda!
We were also delighted to have XinQi Dong, MD, MPH, serve as subject matter expert during the development process of our upcoming Elder Abuse and Dementia module. Dr. Dong not only provided invaluable content input, but also hosted a webinar for academic detailers who plan to go into the field with this topic. Dr. Dong has published extensively on aging, culture, and mental health throughout his career, and has received both national and international awards for his research and policy work on elder abuse. He serves as a primary investigator for two large cohorts, the Chicago Health and Aging Project and the Chinese Health, Aging and Policy Program, examining the relationships between elder abuse, culture, and psychosocial factors and is the editor of the first major book on elder abuse, Elder Abuse - Research, Practice and Policy.
Educational Outreach to Opioid Prescribers: The Case for Academic Detailing
Posted in Publications on 3.15.2017
Pain Physician 2017; 20:S147-S151 • ISSN 1533-3159
In recent years, deaths from accidental overdose due to prescription opioids exceeded deaths from motor vehicle accidents in the United States. Inappropriate prescribing of opioids by physicians may have contributed to this growing epidemic. A variety of approaches have been proposed to address this public health problem, from state legislation on prescription drug monitoring to limits on the quantity of opioids dispensed as an initial prescription. Academic detailing, or one-on-one educational outreach to physicians, has been shown in several randomized trials to be effective in reducing inappropriate prescribing. In a recent review, Drs. Davis, Bateman and Avorn describe how physician training through academic detailing may help reduce the problem of inappropriate opioid prescribing.
Read the full article here.
DC Program Closes Knowledge Gap on EPT
Posted in Updates on 3.6.2017
Alosa Health’s program in Washington, DC is having a measurable impact on healthcare providers’ knowledge of expedited partner therapy (EPT) to manage patients with STIs and their current partners. Among healthcare providers who received academic detailing through our program, none were previously aware that EPT was permitted in Washington, DC. Yet, after participating in academic detailing, all stated they would be willing to prescribe EPT in the appropriate circumstances. We are so proud to see that our work is driving behavior change, and grateful for the continued support of our DC DOH partners at HAHSTA!
The Case for Academic Detailing with Nurse Practitioners
Posted in Publications on 3.1.2017
Journal of the American Association of Nurse Practitioners 2016; 28, 574-575
Academic detailing (sometimes called educational outreach) programs have historically been directed at physicians. However, nurse practitioners (NPs), like other clinical providers, must also stay current with the latest evidence in order to provide the highest quality care to their patients in today’s rapidly evolving healthcare environment. In their editorial, Drs. Doyle-Tadduni and Jackowski describe the benefits to NPs of face-to-face academic, rather than commercial, encounters.
Read the full article here.
Academic Detailing: “Marketing” the Best Evidence to Clinicians
Posted in Publications on 3.1.2017
JAMA 2017; 317(4)
In 1983, Drs. Avorn and Soumerai published the seminal randomized trial that evaluated the effect of academic detailing on clinical practice. In a recent JAMA Viewpoint, Dr. Avorn describes the rationale that led to that trial’s publication as well as a few of the follow-up studies that have been conducted in a variety of settings around the world. Historically, the strongest academic detailing programs have originated in integrated healthcare systems such as Kaiser, the VA, or the nation of Australia. As healthcare in the US moves increasingly from a fragmented, fee-for-service basis to an accountable system of global payment, academic detailing will assume a much more important role in helping to provide clinicians with the best evidence to care for patients.
Read the full article here.
Alosa CEO Wins Committee Appointment
Posted in Updates on 2.21.2017
Massachusetts Governor Charlie Baker recently appointed Alosa Health CEO Cheryl Bartlett to the newly minted Special Commission on Behavioral Health Promotion and Substance Use Prevention. The Commission’s purpose will be to investigate evidence-based practices, programs and systems to prevent behavioral health disorders and promote behavioral health across the Commonwealth. Bartlett is one of 24 commission members in total, and she will serve as the designated expert in community-based public health.
Ulterior Motive in Question with Drug Companies’ Charity
Posted in News on 2.16.2017
The Massachusetts U.S. Attorney’s Office is currently leading a nationwide investigation into drug companies’ charitable contributions toward organizations that provide financial assistance to patients whose health conditions require expensive drugs. These organizations typically cover copayments, alleviating the financial responsibility of patients, while Medicare covers the rest of the cost.
Drug companies may appear to be acting altruistically when they donate large sums of money, but there is concern that ongoing support for financial assistance organizations actually allows them to keep prices high. Specifically, without the existence of these organizations, drug companies would likely be forced to lower their prices in order to remain competitive. However, under the current system, drug companies can make a small contribution to a financial assistance organization and still pick up a profit from Medicare.
At least six companies have been subpoenaed by the Massachusetts U.S. Attorney’s Office. Read the full article here.
MA Program Reduces APMs
Posted in Updates on 1.2.2017
The second wave of Alosa Health’s Massachusetts program to reduce misuse of antipsychotic medications (APMs) in nursing homes came to a close with the 2016 calendar year. While it is too early to evaluate our impact on this group of nursing homes, we are pleased to announce that nursing homes participating in the first wave of our program experienced an overall reduction in APMs prescribing rates. In fact, the decrease in prescribing rates at our participating nursing homes actually outpaced the national and state average. Thank you to our detailers and Massachusetts DPH partners who worked hard to make this a success!
Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy
Posted in Publications on 12.20.2016
In September 2016, the head of the FDA’s Center for Drug Evaluation and Research approved a new drug (etiplersen) for the treatment of Duchenne muscular dystrophy, despite an advisory committee who voted 7 to 3 finding no evidence that the drug had clinical efficacy. Drs. Kesselheim and Avorn recently published a Viewpoint in JAMA where they describe the problematic case of etiplersen. They highlight the troubling fact that the pivotal trials which supported the drug’s approval were based on an outcome that was not likely to translate into meaningful clinical benefit: a change in protein dystrophin levels based upon muscle biopsy specimens. The authors also point out that approving drugs on the basis of such surrogate outcomes may translate into worse outcomes for patients, by exposing them to the risk of adverse events and high drug costs.
Read the full article here.
Alosa Joins MA Public Health Association
Posted in Updates on 12.12.2016
Alosa Health is now a member of the Massachusetts Public Health Association (MPHA), an organization devoted to preventing illness, disease, and injury in the state of Massachusetts and particularly among those most vulnerable to health disparities. MPHA is also an affiliate of the American Public Health Association (APHA). We are so proud to be aligned with the Association and its other members! Thanks for the welcome message and feature on the MPHA blog.
Congress Says ‘Yes’ to Fast Track FDA Approvals
Posted in News on 12.9.2016
Last week Congress passed legislation addressing questions of healthcare regulation and public health funding. The 21st Century Cures Bill was able to gain easy approval in both the House and Senate because it contains provisions that appeal to both sides of the aisle and to various industry and public interest groups.
One of the most salient features of the bill is its loosening up of current FDA standards for approving drugs and medical devices, naturally drawing ire from critics who are concerned that relying on less rigorous standards of evaluation (using types of studies other than the gold standard of clinical trials and using fewer studies to make a determination) will result in ineffective or unsafe products on the market. Advocates of the bill, including representatives from industry, say the new standards will streamline what is currently a bureaucracy-laden approval process and bring beneficial or potentially life-saving treatments to patients more quickly.
Despite lack of consensus around parts of the bill pertaining to FDA deregulation, other features written into the bill, including increased funding for the National Institutes of Health (NIH) and $1 billion earmarked for prevention and treatment of opioid addiction, helped it to gain widespread support. Read the full article here to see what Alosa Health founder Dr. Jerry Avorn has to say.
Contact us for more information.
Bill to Ease FDA Approval Draws Praise and Rebuke
Posted in News on 12.1.2016
Alosa Health founder Dr. Jerry Avorn was quoted in the Wall Street Journal regarding a healthcare bill scheduled for a vote in the House next week. The bill in question covers a breadth of topics from funding for biomedical research to opioid addiction to the FDA’s regulatory processes. The proposal to ease FDA standards for approving drugs and medical devices has elicited support from those in industry who say the current approval process is long and arduous, to the detriment of patients waiting on new treatments. It has also drawn sharp criticism from those in the medical and academic communities who say that relying on fewer studies and studies that adhere to less-strict scientific standards to inform decision-making will result in ineffective or unsafe treatments on the market.
This bill throws into the spotlight a broader question about linking up priorities from opposing groups in order to build a broad base of support for legislation. For instance, the same medical and academic institutions that would likely oppose deregulating FDA processes might be swayed by the promise of funding for research and public health initiatives. What some view as bipartisan compromise, others view as a kind of extortion in which accepting money for medical research cedes control of drug and device approvals to industry. See our founder Dr. Jerry Avorn’s take by reading the full article here.
Contact us for more information.
Healthcare Bill to Fund Research, Overhaul FDA Regs
Posted in News on 11.30.2016
The $6.3 billion bill that has been called “parting gift” to Vice President Joe Biden contains a smorgasbord of healthcare related provisions, including a commitment to additional funding for cancer research through the National Institutes of Health (NIH). Notably, Biden’s son died of brain cancer last year.
Other topics that the bill touches on include mental health, opioid use, Alzheimer’s disease, and regulatory changes pertaining to the FDA and standards used to evaluate drug safety and efficacy. While there is widespread support for the bill among members of both houses of Congress, some are skeptical. The most contentious feature of the bill would relax the FDA’s current standards and introduce a streamlined approval process. Alosa Health founder Dr. Jerry Avorn voiced the concern shared by many in the medical community that a “lower bar” for drug approval will ultimately jeopardize patient safety. Find Dr. Avorn’s full quote in the article here.
Contact us for more information.
PACE Launches Hypertension Training
Posted in Updates on 11.15.2016
Alosa Health’s newly updated hypertension training module launched recently through the PACE program in Pennsylvania, providing guidance on the latest evidence on hypertension treatment goals and recommendations for therapy. In keeping with our mission to deliver the most up-to-date evidence available, our module encompasses recommendations from landmark trials such as ACCORD and SPRINT, neither of which were included in the most recent consensus guidelines last updated in 2004. Primary care practitioners have responded to the hypertension guidelines with positive feedback, commenting that the information is “solid”, “well-organized”, and “helpful.”
Alosa Wins PrEP Bid in Shelby County, TN
Posted in Updates on 11.1.2016
This year Alosa Health will kick-off a new program based in Shelby County, TN to support the county health department’s HIV prevention initiatives. The program will focus on educating primary care providers in high-risk areas about the use of PrEP, or pre-exposure prophylaxis, as an HIV prevention strategy. This initiative is supported by funding through the CDC’s Project Pride. We are looking forward to partnering with Shelby County on an issue that is near to our public health roots here at Alosa Health!
The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform
Posted in Publications on 9.6.2016
High prescription drug prices are increasingly straining the budgets of patients, payors and healthcare systems in the United States. In this JAMA clinical review, Drs. Avorn, Kesselheim and Sarpartwari describe the origins for high drug prices and recommend policy options to help contain these rising costs. They find that per capita prescription drug spending in the United States is more than twice the average of other industrialized countries, and now comprise about 17% of total healthcare expenditures. High prices arise primarily because of government-protected monopolies. Other contributors include the fact that some physicians prescribe high cost drugs when comparable and less costly alternatives are available. Enhancing generic competition, increasing opportunities for meaningful price negotiation by governmental payers, and academic detailing were cited as realistic strategies to help contain prescription drug prices.
Read the full article here.
Forbidden and Permitted Statements about Medications – Loosening the Rules
Posted in Publications on 9.10.2015
The promotion of drugs by manufacturers for uses not previously approved by the FDA (aka off-label use) is controversial because it may lead to more patients being exposed to medicines with an uncertain risk-benefit profile. In an article published in the New England Journal of Medicine, Drs. Avorn, Kesselheim and Sarpartwari describe a 2015 federal judge ruling on a suit between Amarin pharmaceuticals and the FDA regarding the deliberate off-label promotion of a prescription fish oil product. Rather than addressing the practice of off-label prescribing itself, an issue not addressed in the suit, the case pertains to whether or not the FDA can restrict a manufacturer from marketing a drug to a prescriber for an unapproved use. Historically, the right of the FDA to regulate promotional materials has been based upon the government’s substantial interest in ensuring the safety and efficacy of prescription drugs available to the public. However, in recent years, both the courts and the agency itself have relaxed the FDA’s ability to restrict off label promotion, in part so that the government does not restrict “commercial free speech.” The authors discuss the potential negative impact of relaxing the FDA’s ability to police the marketing of drugs for unapproved uses, namely that larger numbers of patients will be exposed to increase risk without a rigorous evaluation of evidence supporting clinical benefit.
Read the full article here.