Category: Vaccines

Pharmacist Vaccination Laws, 1990-2016

Temple University Center for Public Health Law Research Leave a comment

Since the 1990s, there has been a growing movement to improve access to immunization services by giving pharmacists the authority to administer vaccines.

The newest map on LawAtlas.org explores state laws from 1990 to 2016 that give pharmacists authority to administer vaccines and establish requirements for third-party vaccination authorization, patient age restrictions, and specific vaccination practice requirements, such as training, reporting, record-keeping, notification, malpractice insurance, and emergency exceptions.

As of January 1, 2016:

  • Pharmacists were explicitly authorized to administer vaccines in 46 states and the District of Columbia.
  • Thirteen states and the District of Columbia permit exceptions to vaccination requirements for emergencies or epidemics.
  • Ten states grant pharmacists prescriptive authority to administer vaccines (i.e., pharmacists can vaccinate without a third-party authorization).
US map shows every sate except AL, MS, TN, WA have laws
As of January 1, 2016, every state except Alabama, Mississippi, Tennessee, and Washington had laws that authorized pharmacists to vaccinate.

The dataset was created by Cason Schmit, JD, Research Assistant Professor, Texas A&M University, and Allison Reddick, JD, MPH, Associate Attorney at Hill & Ponton, PA.

Check out the latest map and data at LawAtlas.org.

Public Health under the Trump Administration

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By Wendy E. Parmet

The recent report by the National Center for Health Statistics showing a decline in life expectancy in the U.S. in 2015 highlights a point largely overlooked in post-election discussions about health policy under the Trump Administration. The significant increases in health insurance coverage under the ACA have not resulted in population-wide improvements in life expectancy. This is not because the coverage increases aren’t important; without question they have made a difference in the lives of millions. Rather, it’s because health care plays a relatively small role in determining population-level health outcomes.  More important are the so-called social determinants of health, the “conditions in which people are born, grow, work, live and age, and the wider forces and systems shaping the conditions of daily life.” This suggests that the new Administration’s economic, educational, environmental, labor, and housing policies will have more to say about the health of Americans than its proposals for replacing the ACA or reforming Medicare and Medicaid.

Public health policies, and public health law, can also have a major impact on population health. Several years ago, the CDC published a list of the “Ten Great Public Health Achievements in the 20th Century,” which it credited with adding 25 years to life expectancy in the U.S. The list included immunizations, control of infectious diseases, family planning, reductions in tobacco use, work-place and motor-vehicular safety and safer and healthier foods. These goals and other public health objectives, including reductions in opioid use and obesity, remain paramount to preventing further reductions in life expectancy.

To date, little attention has been paid to the incoming administration’s views on most of these issues. Although Trump has nominated Rep. Tom Price to be Secretary of HHS, he has yet to name his picks for the head of CDC or for Surgeon General. The Trump transition website does not mention public health; nor did many public health issues, other than the opioid epidemic, receive much notice during the election. Read More

Losing the Arms Race: Health Policy and Anti-Microbial Resistance

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By Seán Finan

And scattered about it, some in their overturned war-machines, some in the now rigid handling-machines, and a dozen of them stark and silent and laid in a row, were the Martians–dead!–slain by the putrefactive and disease bacteria against which their systems were unprepared; slain as the red weed was being slain; slain, after all man’s devices had failed…

H.G. Wells, The War of the Worlds  

The WHO World Antibiotic Awareness Week ran from 15-22 November. It coincided with similar European and American initiatives. So, in the interests of raising awareness, I thought I would highlight a few figures.

Photo by Rocky Mountain Laboratories, NIAID, NIHAntimicrobial resistance currently causes an estimated 70,000 deaths annually. If current practices continue, the death toll is expected to hit to ten million per year by 2050. That works out at about one death every three seconds.

The threat isn’t limited to increased mortality. Anti-microbial resistance could cast medical practice back to turn-of-the-century standards. Turn of the 20th century, that is. Without antibiotics, the chance of infection turns chemotherapy and invasive surgeries into mortal gambles. During these procedures, the body’s immune system is subject to massive exposure and needs antibiotic support. Even ordinary nicks and scratches can lead to fatal infections without effective antibiotics.

So what is antimicrobial resistance? How does it come about? What can we do to combat it and prevent the “antibiotic apocalypse”?

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Violations of federal antifraud provisions alleged against two hepatitis B treatment producers

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By Wendy S. Salkin

Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.[1]

Meller v. Arrowhead Pharmaceuticals, Inc., et al., complaint filed (C. D. Cal. Nov. 15, 2016)

On November 15th, named plaintiff Yaki J. Meller filed a Class Action Complaint in the United States District Court for the Central District of California against Pasadena-based Arrowhead Pharmaceuticals, Inc., its President and CEO (Christopher Anzalone), and its CFO (Kenneth Myszkowski). Arrowhead is a biopharmaceutical company that, according to its website, “develops medicines that treat intractable diseases by silencing the genes that cause them.”

Among its clinical stage drugs are ARC-520 and ARC-521, which “are designed to treat chronic hepatitis B virus infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure.” ARC-520 is the drug at issue. According to the Complaint, Arrowhead knew but failed to disclose that ARC-520 “could be fatal at its higher doses and that the FDA was unlikely to approve the treatment as a result.”[2] In particular, the Complaint alleges that Arrowhead:

made false and/or misleading statements and/or failed to disclose that: (i) the Company’s ARC-520 was unsafe at certain doses and caused deaths in an ongoing primate toxicology study; and (ii) as a result, Arrowhead’s public statements were materially false and misleading at all relevant times.

According to Meller’s Complaint, in so doing, Arrowhead violated Sections 10(b) (“Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting.”) and 20(a) (“Liability to contemporaneous traders for insider trading.”) of the Securities Exchange Act of 1934, “Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting” and “Liability to contemporaneous traders for insider trading,” respectively, and Securities and Exchange Commission Rule 10b-5, “Employment of manipulative and deceptive devices.”

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Vaccinate Your Children (Says a Federal Judge)

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Flickr Creative Commons-Dan Hatton
Flickr Creative Commons-Dan Hatton

By Gregory M. Lipper

After nearly four years fighting about whether and when employers may exclude contraceptive coverage from employee health plans (and even block others from providing that coverage), it’s perhaps refreshing to see less controversial cases. And few healthcare-exemption cases are less controversial than those brought by parents who object to vaccinating their children. Although the challenged laws are objectively more intrusive than the contraceptive regulations—vaccination laws require parents to get the offending treatment injected into their children—courts thus far have correctly dismissed these challenges with little fanfare.

This dynamic surfaced again in a recent federal trial-court decision in California, in which the court dismissed a federal and state constitutional challenge to California legislation repealing the “personal belief exemption” to requirements that those entering schools and child-care facilities get vaccinated against diseases—including diphtheria, measles, mumps, rubella, and other dreadful ailments. The court acknowledged that eliminating the personal-belief exemption “raises principled and spirited religious and conscientious objections by genuinely caring parents and concerned citizens,” but stated that “the wisdom of the Legislature’s decision is not for this Court to decide.” Because the legislature decided to scrap the personal-belief exemption, California now exempts only those children (1) with actual medical reasons for avoiding the vaccination, (2) who are home schooled, or (3) who qualify for an Individualized Education Program under federal disabilty law. That’s a much more limited and manageable group of exemptees.

Although quite a relief for those seeking to minimize gratuitous suffering from preventable diseases, the court’s decision implicates several knotty legal issues and is worth exploring further.

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Corralling the Herd: California Medical Board Acts Against Anti-Vax Doc

Ross D. Silverman 1 Comment

This summer, California’s strict new childhood immunization law, barring all exemptions except those needed for medical purposes, went into effect for public and private schools, preschools, and day cares. This law was passed as a response to the highly-publicized 2014-2015 multi-state measles outbreak that originated at Disneyland, and also in response to the growing number of California communities with large clusters of families exempting their children from vaccine requirements, putting at risk community protection from vaccine-preventable illnesses.

As I’ve written about before, both here and in articles with Tony Yang, there are many different ways to structure childhood vaccination laws. While much of the attention goes to whether or not states offer parents the right to exempt their children based on religious and/or philosophical grounds — see, for example, the recent American Academy of Pediatrics report supporting mandated vaccination for school and daycare attendance —  there are many other implementation-related details in the laws that can increase or decrease the law’s efficacy at maintaining high vaccination coverage rates. For example, some states may require that exemption requests be filed annually (increases efficacy), some states require only that a form be correctly completed (decreases efficacy), some states allow for historically anti-vax practitioners, such as naturopaths, to complete medical exemption forms (decreases efficacy, and creates a new, permanent loophole for gaining exemptions), some states require that medical exemptions be reviewed and approved by a state public health officer (increases efficacy). Read More

Fighting the Next Pandemic: Airline Vaccine Screens

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By Christopher Robertson

Whether it is Ebola, H1N1, the season flu, or the next nasty bug that we cannot yet even imagine, if we wanted to efficiently spread the disease, one could not do much better than packing several Flight routeshundred people into a cylinder for a few hours, while they eat, drink, defecate, and urinate.  Even more, to make sure that the disease cannot be contained in a particular locality, we could build thousands of those cylinders and move them rapidly from one place to another worldwide, remix the people, and put them back in the cylinders for return trips back to their homes, schools, and jobs.

We are (hopefully) not going to stop airline travel.  But we can make it a lot safer, by ensuring that almost everyone who boards these flights is vaccinated.  That’s the thesis of a new paper out this week.

Airlines carry two million people every day.  And, prior research has shown that airline travel is a vector of disease.  In fact, when the September 11 attacks caused airline travel to fall, seasonal flu diagnoses fell too.

The threat of pandemics is quite real, and more generally, the mortality and morbidity associated with infectious disease is a severe public health burden.  About 42,000 adults and 300 children die every year from vaccine-preventable disease.  New vaccines are on the horizon.

Arguably, airlines have market-based and liability-based reasons to begin screening passengers, whether for vaccinations generally or for particular ones during an outbreak.  Although the states have traditionally exercised the plenary power to mandate vaccinations, and have primarily focused on children in schools, the U.S. federal government also has substantial untapped power to regulate in this domain as well.

Legal Dimensions of Big Data in the Health and Life Sciences

Timo Minssen 1 Comment

By Timo Minssen

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

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Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

Timo Minssen Leave a comment

By Timo Minssen

Dear readers and colleagues,

I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016.

Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, living in Sweden and commuting every week over the bridge to Copenhagen in Denmark – most recently with thousands of terrified refugees and border controls on the way back to Sweden – this year has left me with much astonishment and concern about the state of the European Union and our global situation. It appears to me as if the EU and other global leaders have focused far too much on tiny technicalities, while leaving the bigger issues untouched and disregarding crucial lessons of history. There are so many things that we must learn from 2015’s terrible events and alarming decisions, but also from the hope-giving agreements, incidents and initiatives. For me one of the most important take-aways is that everything is connected and that sustainable, realistic solutions not only require immediate actions. In my view, we need to think about long-term strategies both in more detail and from a bigger perspective. Due to the complexity of our most pressing problems this is a colossal task. It demands more knowledge, better communications, more collaboration and a more effective coordination of  the considerable skills and different competences that are already out there.

Returning to the actual topic of this blog, it becomes evident that this is also very much true for the health sector and the bio-pharmaceutical area. Not only the Ebola outbreak, global health crises, IPR debates, dreadful business models and controversial FTA negotiations, but also scientific break troughs, new therapies, legislative action and novel US and EU approaches demonstrate very clearly how this area is left with many challenges and opportunities. The recently approved US 21st Century Cures Act and the new EU Clinical Trials Regulation, for example, show how legislative activities pursuing laudable goals might lead to unwanted adverse effects if they are not carefully enough considered. Read More

Our Curious Medicare Vaccine Reimbursement System

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By George Maliha, Harvard Health Law Society

As flu season begins, we are bombarded by ubiquitous reminders to get our flu shot. So, it is a good opportunity to reflect on how we provide vaccines to our fellow citizens 65 and older. By law, Medicare Part B covers 4 preventive vaccines (flu, two pneumococcal, and hepatitis B for medium-to high-risk patients). Part D picks up the rest, namely shingles, TDaP, and any other commercially available vaccine. But, that’s where the trouble begins.

When Congress passed Part D, the vaccines recommended for those 65 or older were basically covered by Part B. Now, they aren’t. In 2006, the zoster (or shingles) vaccine came onto the market. In 2010, the recommendations for the TDaP (the P for pertussis or whooping cough being the most relevant here) changed to include the elderly.

But, so what, they’re still covered, right? Read More