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The Drug-Resistant Threat: Incentivizing New Antibiotics

In 2012, Margaret Chan, Director-General of the World Health Organization (“WHO”), suggested that we are entering a “post-antibiotic era,” meaning that “[t]hings as common as strep throat or a child’s scratched knee could once again kill.” (Forbes)  The evolution of antibiotic resistant bacteria has led to the deaths of at least 23,000 annually in the U.S..  Terrifyingly, most of the infections causing these deaths, or deaths complicated by an antibiotic-resistant infection, occur within “healthcare settings such as hospitals and nursing homes.” (CDC – Threat Report)  Unfortunately, pharmaceutical companies have been loath to invest in antibiotics to combat the growing problem simply because it is not profitable, causing a steady decline in new antibiotic drug approvals. (CDC – US Threat)

The problem has not gone unnoticed by the Food and Drug Administration (“FDA”) or Congress.  For FDA’s part, the Agency, along with the Centers for Disease Control (“CDC”), has attempted to improve public awareness of the capabilities of current antibiotics, detailing when and how the drugs should be used. (CDC – Get Smart)  Furthermore, the Agency increased labeling requirements for antibiotics, instructing physicians when to prescribe antibiotics – “only to treat infections that are believed to be caused by bacteria” – and encouraging physicians to discuss proper use with their patients.  Finally, the FDA has created guidance documents for pharmaceutical companies “to evaluate how an antibacterial drug works for the treatment of different types of infections.” (FDA – Resistance)

On the legislative side, Congress passed the Generating Antibiotic Incentives Now Act (“GAIN”) in 2012.  The Act requires the FDA within two years of its enactment to create a list of “qualifying pathogens”, which will then be reviewed every five years.  “Qualifying pathogens” are those that the FDA has identified as posing a serious threat to public health.  The antibiotics that treat these qualified pathogens are known as “Qualified Infectious Disease Products” (“QIDP”).  GAIN also creates incentives for QIDP development.  The GAIN Act provides that any QIDP be eligible for fast track designation and receive priority review for marketing approval rather than proceeding through the standard and cumbersome New Drug Approval process.  Once the drug is approved, the Act grants the QIDP developer an additional five years of market exclusivity on top of that already guaranteed by the Hatch-Waxman Amendments, allowing the branded company to recoup more of its losses before generics enter the market.  (FDA – Innovation Act and PEW Heath Report).  As of October 2013, sixteen antibiotics have been designated as QIDP, with two possibly being approved in 2014. (PEW Heath Report)

Incentivizing antibiotic development may be problematic to implement, primarily because of cost.  We are not used to paying for expensive antibiotics.  A standard course for a current brand-name antibiotic costs around $3,000 per patient.  Compared to current cancer treatments that may cost up to $100,000 per patient, even the most expensive antibiotic is relatively cheap. QIDPs, however, will fall into a category of drugs used to treat rare diseases, which tend to cost nearly $200,000 per patient.  Because QIDPs do not have high potential for profits, the U.S. Government has turned to funding initiatives to assist new antibiotic development.

The FDA’s and CDC’s new policies and Congress’s GAIN Act have already made great steps to encourage the industry to invest in antibiotics.  On July 9, 2013, the FDA issued a proposed rule to establish the “qualifying pathogen” list.  The FDA has granted 24 QIDP designations for upcoming antibiotics.  (FDA Reviewing FDASIA)  Despite these efforts, more can still be done.  The Government needs to create more incentives for the industry to develop these drugs alongside guaranteed moneymakers.  While funding initiatives may encourage pharmaceutical companies, the best encouragement is more likely larger Medicare and insurance reimbursements for existing drugs, granting the industry a better opportunity to remake the money spent in development of the more expensive QIDPs.  (Forbes)  Insurance providers, interest groups, and physicians need to be more active in informing their patients of what to expect from the developing drugs: what the drugs can do, what they cannot do, and just how expensive they are going to be.  In the end, if Margaret Chan is incorrect and this is not the end of the antibiotic era, it is certainly the end of the cheap antibiotic era.

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Belgian Child Euthanasia Bill Sparks Debate

The debate over euthanasia usually revolves around terminally ill adults.  Adults are presumed to be able to make rational, informed decisions about their quality of life and the possibility of ending it.  But in Belgium, this assumption of rationality is being considered in children.

The Belgian Senate approved a bill in December that would allow euthanasia to be administered to a child of any age who repeatedly requests that his or her life be ended.  The bill increases the scope of an existing euthanasia law passed in 2002, which requires that an adult person (1) is competent and conscious, (2) is repeatedly making the request to die, and (3) is suffering unbearably – physically or mentally – as a result of a serious and incurable disorder.  (BBC)  The bill passed in the Belgian Senate would extend the same criteria to children of any age.  There are further restrictions that would apply specifically to children, however:  under the bill, the child must understand what euthanasia is, and their parents and medical teams have to approve the child’s decision to die.  The child must also possess the “capacity of discernment” (a term left undefined in the bill) for his or her request to be considered.  (NYTimes)  The bill next goes to the House of Representatives, where it will likely be enacted.  (USA Today)

In support of the bill, sixteen leading Belgian pediatricians wrote a letter demanding the expansion of euthanasia rights to terminally ill children. They, along with other proponents of the bill, say that giving euthanasia options to terminally ill children is an act of compassion.  Their reasoning is that both children and adults suffer from the same terminal illnesses, so the right to die should equally extend to both groups.  Supporters also claim that terminally ill children are more psychologically mature than their healthy counterparts, which gives them the mental capacity necessary to make such an important decision.  (Deutsche Welle)

Opponents of the bill include religious communities and some bioethics experts.  The Catholic Church has come out in opposition of the bill (USA Today), and an alliance of Catholic, Muslim, Protestant, and Christian Orthodox representatives have published an open letter in opposition.  Carine Brochiner of the European Institute of Bioethics in Brussels equates the right to euthanasia with other rights in Belgium unavailable to children:  “A child cannot buy a house in Belgium.  A child cannot buy alcohol in Belgium.  And this law would allow a child to be killed.  And that is a real problem.”  (Deutsche Welle)  Private citizens are also voicing their opposition. Steve Forbes, the chairman of Forbes Media, published an article calling the practice “HitlerCare.”  (NewsMax)

If the bill passes, Belgium will become the first country to allow euthanasia in children without age restrictions.  Its neighbor to the north, the Netherlands, has long been labeled as the European country most supportive of euthanasia.  The Netherlands became the first country to legalize euthanasia in 2001, and before euthanasia was legalized, the practice was tolerated by government officials.  But even the Netherlands does not allow euthanasia for children under the age of twelve.  (Washington Times)

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California Law Requires Chefs to Wear Gloves

A California law (Section 113961 of the California Retail Food Code) that went into effect on January 1, 2014 prevents restaurant workers in the state from handling ready-to-eat food. (NBC Los Angeles, Inside Scoop SF)  The law was previously only a suggestion in the food safety code, and has now become a requirement.  (Inside Scoop SF)  This makes it difficult for establishments in the industry, such as delis and those serving sushi.  Additionally, the law impacts those cooks who work with breads, fresh fruits, vegetables, and any cooked parts of meals that must be put together for diners.  The law itself requires “chefs to wear single-use disposable gloves while working with prepared foods,” unless the establishment has attained previous approval from the local enforcement agency.  (NBC Los Angeles) Angelica Pappas, the spokeswoman for the California Restaurant Association, opined that the law was not unexpected, and that other states have similar rules, and California is simply catching up.

The purpose of the legislation that Governor Jerry Brown signed into law is to “curtail foodborne illnesses.” (LA Times)  However, this has caused many chefs in the state to say that the law is “confusing, ineffective, bad for the environment, and can compromise a final dish.” (LA Times)  In fact, Neal Fraser a chef based in the state, believes that the law could actually have the opposite impact of promoting food safety.  The Chef believes that the glove requirements will lead chefs to “not wash their hands” which then might increase food-related illness rather than to prevent it. (LA Times)  Jordan R. Berstein, an attorney who has been providing general counsel for restaurant clients, has attacked the law for its lack of clarity calling it a law that was intended to regulate fast food chains, but is now being applied to fine dining establishments. (LA Times, SCPR.org)

On the other than, not all chefs have such a problem with the law.  Niki Nakayama, who makes sushi at her restaurant, stated that “for the most part I use gloves through my whole preparation process and I have no problem wearing gloves for plating something.” (LA Times)  She too, however, stated that she did not know whether the cleanliness of the gloves would remain consistent, and whether it would actually achieve the law’s ultimate goal.  Aditionally, Mary C. Fitzgerald of Safe & Sound food safety consultants is in favor of the law and had stated that “it both raises awareness and raises the bar that everyone’s responsible to prevent foodborne illness.” (LA Times)

Like many restaurants, the law too will have a soft opening over the next six months meaning that restaurants who are not complying with the law will get only warnings rather than harsher violations on their inspection reports.  (LA Weekly, Inside Scoop SF)  The application for exception requires restaurants to show that they are not serving a “highly susceptible population.” (SCPR.org)  Despite this, no one at the Los Angeles County health department was available for comment regarding how specifically the department would seek to enforce regulations and afford exemptions.  (SCPR.org)

The new California law is yet another very interesting example of how the law has the power to impact our daily lives.  Though it is brand new, and therefore yet to be seen what impact the law will have on California restaurants and consumers, it is certain that the law has the potential to impact elements of the law, public health, and economics of the state.

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PPACA Contraceptive Coverage Challenge

On Tuesday, November 26, 2013, the Supreme Court granted certiorari to review portions of the Patient Protection Affordable Care Act requiring employers of a certain size to offer insurance coverage for birth control and other reproductive health services without a co-pay.  In enacting the Affordable Care Act, Congress required large employers who offered health care services to provide a range of preventative care, including no-copay contraceptive services.  However, religious nonprofits were exempted from this requirement, but not for-profit corporations. (NPR) The case will present the issue of whether private companies can refuse to provide coverage for birth control and contraceptives on the basis that it violates their religious beliefs. (CNN)  The case will be heard in the country’s highest court as a result of approximately 50 pending lawsuits filed in federal court by a variety of corporations challenging the coverage benefits under “Obamacare.”  (CNN)

This case will be the first challenge to reach the Supreme Court since it upheld the Affordable Care Act 17 months ago in a 5-4 decision written by the Chief Justice.  (National Federation of Independent Business v. Sebelius)  Beyond that milestone, the recent challenge is significant because it will answer a question with far-reaching consequences — can corporations pray? (USA Today) Hobby Lobby, an Oklahoma City corporation, believes the answer is yes.  In fact, the company closes on Sundays, funnels millions of dollars in profits to ministries, does not sell shot glasses in order to avoid the appearance of promoting alcohol, and does not provide insurance coverage for drugs or devices which it claims are capable of terminating a pregnancy.  (Hobby Lobby Website)

The 10th U.S. Circuit Court of Appeals agreed with Hobby Lobby. It said that the 1993 Religious Freedom Restoration Act protects corporations the same way it protects individuals, ruling that “the contraceptive-coverage requirement substantially burdens Hobby Lobby’s rights under” the law.  (FOX News) The Obama Administration, in its Supreme Court brief, argued that the 10th Circuit was incorrect, and that if the ruling were allowed to stand, it would make the law “a sword used to deny employees of for-profit commercial enterprises the benefits and protections of generally applicable laws.” (FOX News) Furthermore, the Administration and Justice Department point to a long line of Supreme Court cases that have not found a for-profit company to be a religious organization for purposes of federal law. (NPR)

Women’s rights advocates, such as Planned Parenthood, released statements in light of the Supreme Court’s grant of certiorari, expressing that if the Court were to rule in favor of for-profit corporations, that the decision would “create a very slippery slope, giving for-profit employers their own right to impose medical preferences on their employees.” (Planned Parenthood)

All of these views, and more, will undoubtedly be on display when the Court hears the oral arguments that will likely be held in March, with a ruling by late June 2014.  (Politico) Regardless of the Supreme Court’s decision, the nation will be paying attention because the decision is not only important in the context of the Affordable Care Act, but will also answer the question of whether these companies can assert religious freedoms, which will have importance for decades and centuries to come.  (US News)

 

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