When 140 characters just aren't enough ... (tweeting as "msprof")
Washington pundit Tim Carney surely knows his poke at William (Bill) Schultz, currently acting General Counsel of the Department of Health and Human Services, nominated to serve in that same role, is entirely unfair (http://washingtonexaminer.com/tim-carney-obama-nominates-ex-drug-lobbyist-as-top-hhs-lawyer/article/2516459#.UNO-33fkFZJ). It’s a dig at the Obama Administration, but his proclamation that “Obama's lobbyist restrictions were toothless” is entirely ridiculous.
In fact Bill Schultz, who has a fabulous record as a public interest lawyer and public servant, would surely have been brought into the Administration at its outset had he not been registered as a lobbyist for some of his tenure as a partner with the Zuckerman Spaeder law firm. The Administration’s rule was not that you could never ever have been registered as a lobbyist, but that you had not been a lobbyist for two years. And for what cause had Schultz done a lot of lobbying during his private law practice? Carney doesn’t mention this, but Schultz worked (very likely pro bono) for the Campaign for Tobacco-Free Kids; among other things, he was counsel of record for the amicus brief filed on the Campaign’s behalf before the US Supreme Court in the case of Philip Morris USA v. Williams, 549 U.S. 346 (2007). When the Obama Administration began in 2009 a lot of us who have known Bill and his work for a long time despaired that he would not be able to join the Administration for two years because of his lobbying in the public interest.
Carney of course focuses on Schultz’s work for drug companies and hospitals, for which he was for a time registered as a lobbyist. His law firm stopped registering as a lobbyist in 2008; does Carney demonstrate that they were lobbying thereafter? There is a difference between lobbying and lawyering; my understanding is that Washington law firms have over time interpreted the “lobbying” rules very broadly because, well, they are lawyers and don’t like to be found in violation of any laws. Proof of any violations by this law firm, Mr. Carney?
I hate the terrible message this blast sends to young attorneys about their career paths if they wish to work in government or for the public interest. Must they do that forever? If they join a private firm can they never return to government? Consider Bill Schultz as an example. He is a very experienced food and drug lawyer who spent all his years of practice until 2000 working for Nader, for the Food and Drug Administration, for the Department of Justice, and for the House Subcommittee on Health and the Environment. He left government for the private sector in 2001. Carney may have forgotten that George W. Bush became President of the United States then; senior government officials like Bill Schultz with policy perspectives unlike those of a new President either find themselves implementing policies they do not support, or find other work. Where do experienced attorneys find other work? Sure, he might have found a position in the public interest sector (those jobs are pretty scarce); but after working his whole career at the low wages of government and public interest lawyers, should he be condemned for finding a compatible private law firm job? He “cashed out”? If money were his primary goal he could’ve had a law partnership much sooner (and turned down the Administration’s offer to work once again at HHS). Besides, let us note that college tuitions are not discounted for those whose parents have willingly been working for wages far lower than their skills could otherwise command.
I’m also willing to wager that his new partners at Zuckerman Spaeder knew that Bill would not be willing to do anything for any client: that he would bring his public interest spirit into the private sector. Ironically, the one representation Carney mentions is of Barr Laboratories with respect to making the post-coital contraceptive Plan B widely available through insurance coverage. While Barr was financially benefitted by the outcome of that representation, public interest lawyers and public health personnel nationwide cheered the result. This was an instance when a good outcome for industry was also a good outcome for the people.
While I have railed against “the revolving door” throughout my career, I’ve also recognized that there must be reasonable rules to define when a person has a conflict of interest, real or perceived, that should preclude that person’s appointment to a high government job or, when there, participation in particular matters. Young attorneys should not have to fear that they can never move from government or public interest work into the private sector, at the risk of never being able to move back. They might well hesitate to start in the government in the first place.
And the government should not have to forgo the continuing service of dedicated public servants like Bill Schultz.
If successful in November, the ballot measure is likely to be challenged in court by manufacturers, explains Marsha Cohen of UC-Hastings.
2012-08-10 03:20:10 PM
Given California's status as a major center of various food movements, it is not surprising that The California Right to Know Genetically Engineered Food Act qualified for the November ballot. Proposition 37 will mandate labeling of most processed foods and raw agricultural commodities that have been genetically engineered. It will also forbid any statements or implication, in labeling or advertising, that such foods are "natural." Although the opposition is not yet in high gear, it seems likely that concerns about new technology applied to our food and the simplicity of the proposition's goal (let us know, so we can choose) will combine to make passage very likely, as early polls suggest. Passage will be just the beginning of a legal battle over California's right to impose this labeling requirement on the food industry.
Genetically engineered (GE) foods are a recent phenomenon, but almost no plant or animal we eat would have had a look-alike in the Garden of Eden. Man has bred plants and animals over the millennia for traits deemed desirable, among them taste, size, pest resistance and heat or cold tolerance. But selective breeding has always been limited by reproductive biology.
In contrast, genetic engineering radically expands the potential to modify plants and animals; it is also simpler and more precise than earlier techniques. The two most successful modifications of plants thus far have added to grains a soil bacterium (Bt) that naturally produces an insecticide and a gene that protects crops from the herbicide Roundup. Bt crops can be grown with reduced amounts of pesticides. Herbicide can be spread on fields planted with "Roundup Ready" crops whenever needed in the growing cycle. These benefits don't show up directly in the marketplace. In contrast, "golden rice" rice engineered to produce beta carotene, a Vitamin A precursor could help eliminate a serious nutritional deficiency in some parts of the world.
Many consumers fear GE foods. Are their fears rational? The well-regarded consumer advocacy group the Center for Science in the Public Interest sees benefits in the technology, and no adverse health effects to date, but urges greater surveillance and better government regulation. The FDA has no pre-approval authority over new plant crops but oversees them only through a voluntary notification process. In contrast, the FDA considers GE traits in food animals to be new animal drugs, and subjects those to pre-market testing and approval, including a required showing that there be a "reasonable certainty of no harm" to humans from the resulting food products.
GE crops and some GE animals raise environmental concerns, which are under the purview of the USDA and the EPA. Plant seeds can and do travel, raising risks of weeds with undesirable GE traits; in fact, Roundup-resistant weeds have been identified. Organic farmers are concerned about contamination of their fields by GE crop varieties. Many knowledgeable observers would like considerably better oversight of genetic engineering creations, and enforcement of existing use restrictions, to protect the environment.
While you have not yet tasted a GE animal (a fast-growing farmed Atlantic salmon is currently under consideration at the FDA), unless your diet has been exclusively organic you have likely consumed some GE products (but since they are unlabeled, you would not know that you had). Almost 90 percent of corn grown for feed, and ethanol use, and used in the corn meal that is part of many processed corn products is GE, as are more than 90 percent of soybeans and sugar beets.
Federal law does not require labeling of GE food ingredients. In a 1992 policy statement, the FDA stated that in its view, GE foods do not differ from other foods "in any meaningful or material way" or present any different or greater safety concerns than foods developed by traditional plant breeding methods ("Statement of Policy: Foods Derived from New Plant Varieties," 57 FR 22984 (May 29, 1992)). The FDA finds a difference "material" only if it relates to the attributes of the food itself, rather than to its method of production. Labeling would only be required if the GE food poses special health or environmental risks or would confuse the consumer about its attributes (for example, if it had a different nutrition profile, or required different storage or preparation methods).
The FDA also has concerns about "negative" labeling: that is, "this product has no genetically engineered ingredients." In draft guidelines published in 2001 for the voluntary labeling of foods as having been developed either with or without GE techniques, the FDA indicated it would deem misleading a statement that a food is not GE or contains no GE ingredients if there is an implication that the labeled food is superior to foods that do not bear such labeling. The agency has taken enforcement actions based on this stance.
Industry from the beginning resisted labeling its GE products, the first of which, approved in 1993, was milk from cows treated with a synthetic growth hormone (recombinant bovine somatotropin, rBST) that increases milk production. Because milk products from these cows are indistinguishable from other milk products, the FDA refused to require labeling. The state of Vermont, however, adopted a statute in 1994 requiring milk produced with the use of rBST to be labeled as such when offered for retail sale in the state. In the lawsuit that followed, a U.S. Court of Appeals for the Second Circuit majority in International Dairy Foods Association v. Amestoy, 92 F.3d 67 (1996), struck down the statute as a violation of the milk producers' First Amendment rights (not reaching commerce clause challenges), deeming the labeling to be forced speech. Applying the test in Central Hudson v. Public Service Commission of New York, 447 U.S. 557 (1980), the court found Vermont's interest not to be substantial; it had not claimed health or safety concerns as a basis for the law, but only "strong consumer interest" and the public's right to know.
Dissenting, Judge Pierre Leval found Vermont's concerns to be broader and substantial, "including worries about rBST's impact on human and cow health, fears for the survival of small dairy farms, and concerns about the manipulation of nature through biotechnology"; Vermont was not seeking only "gratification of consumer curiosity." The Second Circuit subsequently distinguished Amestoy in upholding against a First Amendment challenge New York City's requirement that certain restaurants disclose calorie counts, finding that disclosure reasonably related to the goal of combating obesity (New York State Restaurant Association v. New York City Board of Health, 556 F.3d 114 (2d Cir. 2009)). The array of concerns included in the findings and declarations in Prop 37 seem likely to establish "substantiality" of the interest sufficient to meet First Amendment objections like those upheld in Amestoy. (Somewhat ironically, given the history, Prop 37 exempts from its labeling mandate food derived from an animal not itself genetically engineered, even if it has been fed or injected with a GE food or drug (proposed Health & Safety Code §110809.2(a)); that is, it won't require dairy products containing milk from rBST-injected cows to bear a GE label).
Legal challenges based upon federal pre-emption and the Commerce Clause will loom larger over the initiative. The Food, Drug, and Cosmetic Act contains some specific pre-emption provisions on food labeling (21 USC §343-1), but none relevant to labeling foods as genetically engineered. Pre-emption, of course, may be implied, leaving us to ask whether the Prop 37 labeling requirement would be an obstacle to the accomplishment and execution of congressional objectives.
In Dowhal v. Smithkline Beecham Consumer Healthcare, 32 Cal.4th 910 (2004), the California Supreme Court unanimously held that Prop 65 warnings could not be required on over-the-counter stop-smoking aids sold in California (notwithstanding specific language in the FDCA exempting Prop 65 from express pre-emption) because of a direct conflict with an FDA-mandated warning. The court added that the FDA had the authority to prohibit the Prop 65 warning, even if literally truthful, if it deemed it misleading. The FDA has stated that the GE status of a food is not a material fact, and that labeling a product as not containing GE ingredients misleads consumers by implying product superiority. Does a GE-content label, extending the FDA's reasoning, mislead consumers by implying product inferiority, and thus conflict with FDA authority? If so, the Dowhal precedent will bode ill for at least part of Prop 37. If their pre-emption argument fails, manufacturers will surely claim the labeling law imposes an unconstitutional burden on interstate commerce. Manufacturers would likely be forced to make the California-required disclosure on products destined for other states, because distribution systems don't necessarily follow state lines. How much of a burden is the need to print separate labels itself enough? is the state allowed to impose?
The initiative also requires a label on raw GE agricultural products offered for retail sale, either on the package or, if not packaged, on a retail store shelf label. Because shelf labels impose only a minor burden on the producer or distributor to notify the immediate purchaser of the product's GE status the facts underlying the commerce clause arguments will be different from those involving processed food and prepackaged raw produce. Produce moving entirely within California may fall outside FDA jurisdiction, so its views on whether this labeling is misleading may be irrelevant.
The initiative's prohibition on using the term "natural" to describe GE food might be hard for its opponents to eliminate. There is no federal regulatory definition of "natural"; the FDA has not objected to the use of the term to describe a food without added color, artificial flavors, or synthetic substances.
Whatever its potential legal flaws, Prop 37 poses the policy question whether GE foods ought to be labeled. Industry's vehement objections to labeling when the technology was new may have been a strategic error. If labeled from the beginning, consumers by now might have accepted them. Surely GE foods that provide a direct benefit to consumers will find a market, albeit not among those who limit their purchases to organic food. If GE salmon is significantly cheaper than its nonmodified counterpart, will it find willing purchasers even with the GE label? Industry feared the shunning of these products (deemed "Frankenfoods" by some, especially in Europe), but instead created a situation where consumers worry, mostly needlessly, that harm is lurking, unlabeled, in their lunch. As CSPI concluded in its 2003 report, "Holes in the Biotech Safety Net," the apparent safety of current GE crops does not mean they should not receive thorough safety review, sufficiently transparent to assure consumers they are safe. If there were adequate assurance of product oversight, perhaps consumers wouldn't be as concerned as many are to know which products on the supermarket shelves contain GE ingredients.
Marsha Cohen is a long-time member of the Hastings College of the Law faculty. She teaches and writes about food and drug law, served on California's Board of Pharmacy and is co-author of Pharmacy Law for California Pharmacists.
Reprinted with permission from the August 10 7 2012 edition of The Recorder. © Copyright 2012. ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited. In Practice articles inform readers on developments in substantive law, practice issues or law firm management. Contact Vitaly Gashpar with submissions or questions at vgas email@example.com.
Today's New York Times points out, accurately, that whether a person harmed by a prescription drug can or cannot recover damages from the manufacturer depends upon whether the manufacturer is the "pioneer," seller of the brand-name product, or is, instead, the manufacturer of its generic equivalent. The harm can be identical -- but whether or not you recover appears much like a lottery. (Even more like a lottery than the article indicates: if you received a "generic" made by the brand-name manufacturer, and such products do exist, you can recover.) This is the result of the decisions in Wyeth v. Levine, 129 S.Ct. 1187 (2009) and Pliva v. Mensing, 131 S.Ct. 2567 (2011), both asking whether the suits in state court are preempted by federal law.
However, in California, the result can be the same, thanks to the decision in a California Court of Appeal case, Conte v. Wyeth, 168 Cal.App.4th 89 (1st Dist. 2008). Persons harmed by generic prescription drugs in California may bring suit against the pioneer/brand-name manufacturer, even though they were not prescribed that manufacturer's product, for negligent misrepresentation. The Conte court (departing from decisions reaching the opposite result in other jurisdictions)found that the brand-name manufacturer, which controls what is on the label not just of its own products, but also of those of generic manufacturers whose labels must be identical, has a duty to formulate its product warnings with care, and that duty extends to patients whose doctors foreseeably rely on its product information, even if they are dispensed a generic equivalent.
The Times should follow up with a parallel story about medical devices. In that arena, where Congress decided there should be preemption of state regulation, persons injured by medical devices that entered the market after approval of a premarket application cannot bring state torts suits. In contrast, those injured by medical devices that entered the market via the so-called 510(k) exception -- devices that are "substantially equivalent" to previously-marketed devices -- may bring such suits. Whereas the vast majority of prescription drugs dispensed these days are generics, the vast majority of medical devices enter the market via 510(k) -- so there are fewer persons affected by inability to bring suit over medical devices than over prescription drugs.
While the new drug for cystic fibrosis, Kalydeco,will only benefit a small number of patients (about 1200 in the United States), it is the very first therapy that treats the cause and not just the symptoms of this devastating gene-linked disease. It has been more than two decades since the gene responsible for CF was identified; genetic sequencing discoveries haven't quickly led to therapies. But surely this success will hasten additional developments, certainly for other CF sufferers and probably more generally. FDA's approval of this "orphan drug" -- a drug for a condition suffered by fewer than 200,000 potential users in the United States, and for which there are granted additional years of protection from competition -- came three months before its deadline. See a story about this drug approval at www.nytimes.com/2012/02/01/business/fda-approves-cystic-fibrosis-drug.html?scp=2&sq=cystic%20fibrosis&st=cse.
The new drug for basal cell carcinoma -- the mostcommon form of skin cancer, and the most common cancer suffered in the United States-- will affect a considerably larger number of patients. While most people diagnosed with one of these cancers have it removed and have no further consequences, in some the cancer has spread, either locally or elsewhere in the body, and there has been no other treatment option. The drug, called Erivedge, was successful in arresting the disease in a significant percentage of patients. This drug works by inhibiting a pathway to growth of this carcinoma, a pathway researchers first had to find. This drug approval justifies the approach todrug development followed here of first finding such a pathway, and may speed the development of new therapies. FDA's expedited review led to approval two months before than its own deadline. The approval was covered at www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/01/31/BA5N1N0KCH.DTL.
As I noted below (see 9/23/2011 entry), when everyone required a prescription to obtain Plan B, some states circumvented prescription requirements to make this emergency contraception pill widely (and quickly) available. California Business and Professions Code section 4052.3 gives pharmacists who have completed a short training course the authority to furnish prescription emergency contraception drugs under a standardized procedure developed, approved, and posted online by the Pharmacy and Medical Boards. This authority remains in place for pharmacists to use when a teenager who cannot legally purchase Plan B One Step over-the-counter is in need of the drug. That is, while Plan B One Step is prescription-only for those under age 17, California pharmacists essentially may prescribe and dispense it for them, including on a precautionary, advance-of-need basis. So the HHS decision not to follow FDA’s recommendation to make this drug over-the-counter for everyone will have less impact in California than in most other states.
Three points about medical device regulation (with #3 the one that might make you crazy):
Federal law supersedes state law with respect to controlled substances -- that is clear -- so the states cannot ease (but can add) restrictions on federally-controlled substances. Under federal law marijuana is a schedule I controlled substance, the most restricted, and cannot be grown, bought, sold, or possessed. Schedule II through V controlled substances, in contrast, can be sold by prescription in pharmacies, subject to various restrictions. For decades the federal Drug Enforcement Administration (DEA) has been petitioned to reschedule marijuana from Schedule I to Schedule II so it could studied and, if effective, made available in pharmacies for medical use, but DEA has denied those petitions (and prevailed in court review of its decisions). With all due respect to the judiciary: the Feds are wrong, and a petition to reschedule should be granted.
Schedule I drugs are those for which "there is a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use of the drug under medical supervision" (21 USC section 812(b)(1)). Schedule II drugs are those for which "there is a high potential for abuse, a currently accepted medical use, and abuse may lead to severe psychological or physical dependence" (21 USC section 812(b)(2)). (Decreasing levels of risk from use define Schedules III to V.) The DEA position is that there is no currently accepted medical use in treatment for marijuana. And yet ...
President Clinton's drug czar asked the National Academy of Sciences Institute of Medicine to study that very question in 1997, after the first state laws on “medical” marijuana (presumably expecting the answer to be "no"). But the expert IOM panel found to the contrary. Its publication, Marijuana and Medicine: Assessing the Science Base (1999) (reissued for lay readers in 2000 as Marijuana As Medicine?: The Science Beyond the Controversy and available to be read at www.nap.edu), while not finding evidence for all the claimed benefits of marijuana, found evidence for some, and urged more study of those and others. The IOM experts' conclusions should've led to rescheduling, and if it had, we would have marijuana-based drugs in pharmacies by now. Companies have expressed interest in safer ways of marijuana administration than inhalation, such as skin patches, but cannot even study potential products unless the drug is rescheduled. So DEA could have averted the horrible mess we have today.
California voters approved medical use of marijuana but rejected liberalization of recreational use of marijuana in a vote last year. The two issues should be separate, for many reasons. Does anyone know a Californian who has tried, but failed, to get a marijuana card? My understanding is that there are physicians who (in what I regard as a serious breach of medical ethics, if not also the law) are sympathetic to most any story of “need” for this drug (at least, if you can afford their fee). So the “medical” part of “medical marijuana” for many is our California inside joke. Those whose health status could benefit from uses of marijuana might well want to have scientific evidence available in support of a substance before they ingest it (and to have their health insurer, and their personal physician, be comfortable prescribing and paying for it).
What we obviously need is a national conversation about marijuana prohibition: is it really worth the cost? Wouldn’t we rather have American industry provide us with a safe product, that could be taxed like alcohol, and would eliminate the destruction of our forestlands for drug-cartel-run illegal pot farms? Unfortunately, drugs being one of those third-rail issues in politics, no first-term President who wants to be a two-term President can lead the conversation. For many marijuana is their substitute for scotch, or beer, or fine wine, all of which cause endless health and social problems but are still tolerated. Reserving the "medical" designation for drugs prescribed for known medical purposes -- with the benefit of the physicians and pharmacists whose job it is to protect us in our interactions with pharmaceuticals – should be a critical goal.
The New York Times blog post, For Many, a Life-Saving Drug Out of Reach, by Maia Szalavitz, http://opinionator.blogs.nytimes.com/2011/09/22/for-many-a-life-saving-drug-out-of-reach/?scp=1&sq=naloxone&st=cse, makes a compelling case for the drug naloxone (trade name: Narcan) being widely available without the barrier of prescription requirements. Only its timely use can save lives.
FDA determines which drugs are available only by prescription. A drug is to be limited to prescription-only status if, because of its “toxicity or other potentiality for harmful effect … or the collateral measures necessary to its use, is not safe for use” except under the supervision of a licensed prescriber (21 USC §353(b)(1)). I don’t know whether anyone has petitioned FDA to make naloxone an over-the-counter drug. While states can require prescriptions for drugs that FDA deems over-the-counter, they don’t have the authority for the reverse. And yet …
Some states successfully circumvented the prescription requirements before, to make emergency contraception (also needed in a timely fashion) widely available before FDA changed its status to OTC. The same could easily be done for Naloxone. California, for example, passed Bus. & Prof. Code section 4052.3, which gave pharmacists who had completed a short training course the authority to furnish those prescription emergency contraception drugs under a standardized procedure developed and approved (and posted online) by the Pharmacy and Medical Boards. The drugs still were “prescription only,” but pharmacists were given the authority, essentially, to prescribe them – including on a precautionary, advance-of-need basis. The template is there, ready for amendment . . .
Oxycodone isa powerful pain medication that has been a favorite ofdrug abusers. It got the nickname "hillbilly heroin" for its initial popularity in rural rather than urban areas. Pharmacies have feared stocking it because of robberies -- and have even posted signs indicating they didn't carry it.Floridabecame the center of oxy abuse in recent years, thank tocontrolled substance laws weaker than those of other states that allowed physicians to dispense these drugs from their offices and didn't mandate an electronic monitoring system for these prescriptions, as today'sNew York Times detailed(http://www.nytimes.com/2011/09/01/us/01drugs.html?_r=1&scp=1&sq=pill%20mill%20&st=cse).
There's a lot of money to be made by unethical physicians (and pharmacies) that prescribe and dispense without the"legitimate medical purpose" required by federal regulation (21 CFR 1306.04(a)), and a lot of money to be made by reselling these pills in places where they are harder to obtain. The tricky problem, though, is that these and similar drugs areeffective for their pain-killing purpose and needed by many people. Untreated pain is a significant health problem; people with chronic pain need treatment to function. Many health care providers are hesitant to treat people in pain with sufficient medication, for fear oflegal consequences. Most states have adopted laws or guidelines on pain management to assist health professionals whose obligation to adequately treat people in pain is as important as their obligation to avoid providing drugs for those without legitimate need.Unfortunately, there areno easy solutions for an ethical physician trying to determine the legitimacy of a patient's symptoms, especially a new patient.