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Ordinance Requiring Drug Manufacturers to Fund Disposal Program Upheld, Drug Manufacturers Appeal

Posted Nov 14 2013 12:00am
Furmanek Blog In August of this year, a federal district court upheld a California ordinance requiring drug manufacturers who sell drugs in Alameda County to implement and fund a drug disposal program.  This ordinance, which shifts the costs of drug disposal from local governments back to the originators of the drugs, is the first of its kind but if sustained it won’t be the last.  In December 2012, PhRMA, the trade organization for drug manufacturers, challenged the ordinance on constitutional grounds, stating that it impermissibly interfered with interstate commerce.  The District Court disagreed.  Facing the possibility of incurring massive costs if such ordinances were implemented nationwide, PhRMA now appeal s.

Alameda County’s ordinance provides that manufacturers of drugs which are sold or distributed in Alameda County are responsible for operating “Product Stewardship Programs.”  These programs must pay for the costs of “collecting, transporting and disposing of Unwanted Products collected from Residential Generators and the recycling or disposal, or both, of packaging collected with the Unwanted Product.”  Additionally, the manufacturers are expected to pay administrative fees associated with enforcing the ordinance, which are estimated at $200,000 annually.  The ordinance prohibits manufacturers from shifting any of these costs to the consumers.

PhRMA argued that the ordinance was a per se violation of the Commerce Clause because it discriminated against interstate commerce by shifting local costs to interstate manufacturers, who would presumably shift these costs to consumers nationwide.  The District Court rejected the assertion that this was the type of discrimination which implicates the Commerce Clause.  Because PhRMA failed to demonstrate, or even argue, that the ordinance favors in-state drug manufacturers over out-of-state manufacturers, the Court stated there was no per se violation of the Commerce Clause.

The Court went on to hold that the ordinance did not attempt to directly regulate interstate commerce because the ordinance applies only to activities which occur within Alameda County, i.e. the sale, distribution and disposal of drugs within that jurisdiction.  Next, the Court held that the balancing test used for activities which have an indirect effect on interstate commerce was likewise unmet.  Alameda County had shown a legitimate interest in regulating drug disposal for health and environmental reasons and PhRMA failed to show that its burden in funding the program outweighed those interests.

This is a case to watch.  If this ordinance is upheld, similar ordinances will likely be enacted throughout the rest of California and potentially around the United States.

1. Ed Silverman at Pharmalot reports on the FDA’s proposed rule allowing generic drug manufacturers to make safety-related changes to their products’ labels, a rule that would “mean[] that generic drugmakers could face the same sort of liability over product labeling as brand-name drugmakers.”

2. At Drug and Device Law, Steven Boranian comments on a recent decision in a line of cases in which a plaintiff who seeks to hold the manufacturer of an innovator drug liable for injuries caused by a different manufacturer’s generic copy:  “Add another opinion to the “innovator liability” scorecard , and join us in foretelling that Conte will eventually collapse under the mountain of well-reasoned authority that is piling up against it.”

3. Writing at The Hill’s RegWatch blog, Julian Hattem quotes FDA Commissioner Margaret Hamburg on the pending pharmaceutical compounding legislation: “Believe me, it’s not that FDA is looking for a whole lot of new responsibilities, but when there is a health and safety problem like this where we think that we have the expertise and where clearly there should be national standards, we do believe that we should be given the authority that we need.”

4. In an essay in the New York Times entitled “Slow Dancing with Part D”, Jane Gross explains how a report from the Kaiser Family Foundation made her realize that her Medicare Part D plan “was an outlier … one of only two with premium increases in the 50 percent range .”  Gross writes: “Does this mean I have to reconsider reconsidering? Be a responsible consumer? Just the prospect of vetting these plans year after year exhausts me. Open enrollment ends Dec. 7, which gives me a few days to kick the can down the road.”

5. Finally, Arthur Caplan and Nirav Shah argue in an opinion piece in JAMA that New York’s new requirement that “unvaccinated health care personnel in regulated settings to wear a surgical mask in areas where patients or residents may be present … is absolutely consistent with sound and ethical public policy.”

paradiseLGjpg_1 The Food and Drug Administration (FDA) has decisively entered the debate regarding the health risks of artificial trans fatty acids in foods.  On November 8, the FDA announced its “tentative” determination that partially hydrogenated oils (PHOs), also known as trans fatty acids, are no longer generally recognized as safe for human consumption.  The FDA cited research by the American Heart Association (AHA), the World Health Organization, the American Dietetic Association, the Institute of Medicine, and the FDA Food Advisory Committee Nutrition Subcommittee demonstrating that trans fats increase the risk of coronary heart disease.  Trans fats simultaneously raise levels of bad cholesterol and lower good cholesterol , among other adverse negative health effects.  In the FDA Press Release , Dr. Margaret Hamburg, Commissioner of the FDA, stated that reduction in trans fat intake “could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”

This is not the first move by the FDA to address the heavily documented health risks of trans fats.  Ten years ago, the FDA implemented regulations that required information about the trans fatty acid content in foods and dietary supplements to be declared on the Nutrition Facts label .  As a result, the label now identifies the total fat, saturated fat, and trans fat content.  While not directly reducing or eliminating trans fats from American diets, the label requirement forced transparency on the part of food manufacturers and provided consumers with information on which to base purchasing decisions.  It also incentivized manufacturers to scale down on the use trans fat in food production.

If the FDA determination is finalized, PHOs would no longer be permissible ingredients in food products without prior approval by the FDA as a safe food additive.  Food additives , by statutory definition include substances that “result[] or may reasonably be expected to result, directly, or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use).”  The definition excludes several types of substances that are regulated under separate provisions, including pesticide chemicals, pesticide chemical residues, and color additives.  All food additives that are not generally recognized by qualified scientific experts to be safe under the conditions of use are thus classified as not safe for market entry.  Only after a generally recognized as safe (GRAS) determination by the FDA may a food additive enter the market as an ingredient in any given food product.

The FDA has a well-established regulatory process for determining whether a food additive is GRAS.  The FDA maintains GRAS listings in the Code of Federal Regulations that act as a sort of recipe for food manufacturers.  These complete listings are available here , here , and here .  Generally, if a food additive conforms to that published GRAS listing, including the specific amount, intended use, good manufacturing practices, and any limitations, it may be used as an ingredient without prior FDA assessment.  For example, caffeine is a GRAS listed substance for use in cola-type beverages.  When added to other food products, however, caffeine is no longer considered GRAS and the FDA can institute an enforcement action against those products where there is a concern about public safety.  This scenario played out several years ago with regard to drinks combining alcohol and caffeine .

The announcement is seen by those in the health and nutrition fields as an energizing sign of life in a recently limp FDA.  Marion Nestle, a professor at New York University, proclaimed in an interview with the New York Times “[t]he FDA is back!”  Likewise, organizations such as the AHA and the Center for Science in the Public Interest (CSPI) that have been advocating for increased regulation over trans fats praise the FDA’s move, though they emphasize that action is long overdue.  CSPI originally petitioned the FDA for inclusion of trans fat information on the label in 1994 and subsequently in 2003 to prohibit use of PHO as a food ingredient.

It appears that the FDA anticipates phasing-in of the GRAS requirements, and has solicited the public for feedback on several aspects of scope and implementation.  Specifically, the FDA asks for data supporting other approaches, input on the estimated timeframe to reformulate products to bring them into conformance, special considerations for small business, and any other foreseen challenges to such an approach.  The comment period is open until January 7, 2014.

Kate Greenwood_high res 2011 comp Cross-Posted at Bill of Health

As I have blogged about before, including in this post from 2010, and this one from 2009, about 1 in every 160 deliveries in this country ends in a stillbirth, and all too frequently no one can say why.  An article by Robert Goldenberg and colleagues in this month’s issue of the American Journal of Perinatology suggests that the knowledge gap is likely to persist.

As Goldenberg explains, the three tests that provide the most information about what caused a stillbirth are (1) an autopsy, (2) an examination of the placenta, fetal membranes, and umbilical cord, and (3) a karyotype (a test for chromosomeabnormality).  Of the members of the American College of Obstetricians and Gynecologists who responded to a 2011 survey, however, 23.3 reported that they infrequently ordered an autopsy when a stillbirth occurred (0.4 percent reported that they never did) and 24.8 percent reported that they infrequently ordered a karyotype (0.3 percent reported that they never did).  These results comport with the findings of a qualitative study  published in 2012 in BMC Pregnancy & Childbirth.  The authors, Maureen Kelley and Susan Trinidad, reported that obstetrician-gynecologists in two focus groups “would not routinely offer an autopsy to the parents, but would conduct one if requested. Some would offer/order lab work on the placenta if the cause of the stillbirth were not known.”

A surprisingly high 30.2 percent of the doctors who responded to Goldenberg’s survey indicated that they frequently, but do not always, review the results of post-stillbirth testing; an additional 11.9 percent admitted that they infrequently review such results.  The survey also revealed that “the large majority of stillbirth certificates are filled out prior to the return of all test results”, some “by providers other than the physician”, “making it “highly likely that that the vital statistic cause of death reports are inaccurate.”

As Goldenberg notes, there is, as with many surveys, the possibility of a response bias, since obstetricians who were interested in stillbirth were more likely to respond.  In practice, the percentage of physicians who do not order the appropriate tests may be even higher than the survey revealed.  The failure to order the appropriate tests and then interpret and report their results has obvious public health implications.  Goldenberg explains that, despite advances, “the U.S. stillbirth rate is among the highest in developed countries, substantial disparities remain in stillbirth rates between various populations of U.S. pregnant women, and about one-third of stillbirths may be preventable.”  Further study is needed and better data is a necessary first step.

Failing to order the appropriate tests can also harm individual grieving families.  Soo Downe and colleagues conducted a qualitative interview study , published earlier this year in BMJ Open, and found that while “[f]ifteen [of the twenty-five parents interviewed] expressed a strong drive to find out why their baby died”, just ten had had an autopsy.  These parents “emphasized the importance of discussions and accurate information about maternal and child blood tests, placental investigations, postmortem examination and any other tests that could be conducted.”

To improve stillbirth-related knowledge and practice among obstetricians, Goldenberg recommends addressing the relevant issues during residency, in continuing medical education programs, and in grand rounds.  Learning how best to manage a relatively rare occurrence like stillbirth is likely to continue to fall low on the list of priorities of busy physicians with competing obligations, though.  More promising, I think, is Goldenberg’s recommendation that hospitals to help by, among other things, developing protocols and standardized order sheets.  Goldenberg’s survey showed that  ”only about half the hospitals had written guidelines for evaluation and management of a stillbirth, and only 25% of the respondents had preprinted orders at their hospital for stillbirth tests.”  Remedying this would help physicians and patients navigating an exquisitely difficult time; it could also go a long way to improving the current quality and quantity problems with stillbirth data.

*I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue.  (My prior posts are here , here , here , and here ).  Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.

coleman_carl_lg2 At last week’s 44th Union World Conference on Lung Health in Paris, one of the main topics of discussion was the World Health Organization’s recently released 2013 Global Tuberculosis Report .  On the bright side, the report confirms a steady decline in the prevalence, incidence, and mortality of TB.  The world is on track to meet the 2015 target of a 50% reduction in the TB mortality rate by 2015, as compared to 1990.

Yet, despite this good news, many aspects of the report remain disturbing.  Of particular concern is the limited progress achieved in diagnosing and treating multi-drug resistant (MDR) TB .  WHO estimates that, worldwide, 3.6 percent of newly diagnosed TB cases and 20 percent of previously diagnosed TB cases involved drug-resistant strains.  But these averages hide considerable regional variation .  In some countries, MDR-TB is estimated to be present in more than 20% of new TB cases and more than half of previously diagnosed cases.

These numbers, however, are just estimates.  A pervasive concern is that national detection systems fail to identify about 1 in 3 people who develop TB.  The percentage of missed cases is even greater among persons with MDR-TB: WHO estimates that less than a quarter of those with MDR-TB have ever been diagnosed.

WHO has called on the international community to scale up efforts at TB detection, as the first step in a comprehensive process of global TB care.  Ideally, detection will be accompanied by access to appropriate treatment, both for the benefit of the individuals who are detected and to reduce the further development of drug-resistant strains.  But, unfortunately, this is not always the way things work.  In 2012 , of the 94,000 TB patients detected with MDR-TB, only 77,000 were started on second-line treatments.  In some countries, the treatment gap was even greater; in the African region, only half of those detected with MDR-TB were provided with second-line treatment.  According to WHO, ensuring that a diagnosis of MDR-TB is routinely accompanied by access to high-quality treatment “will require high-level political will and leadership and more collaboration among partners, including drug regulatory authorities, donor and technical agencies, civil society and the pharmaceutical industry.”

In the meantime, what are the ethics of diagnosing individuals with MDR-TB if treatment will not be forthcoming?  From the perspective of the individual being tested, the diagnosis comes with a host of potential harms, including stigmatization, discrimination, and even detention .  If access to treatment – or even humanely administered isolation – cannot be assured, individuals who are given the choice to be tested might reasonably refuse.

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