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July 2, 2013 by Thomas McGarity

Anything but Generic: Supreme Court Preemption Opinion Calls for Correction from Congress and the FDA

Lost among the high-profile opinions that the Supreme Court issued during the past two weeks was a case that attracted little media attention, but is of great importance to the millions of Americans who take generic drugs.

Karen Bartlett, a secretary for an insurance company filed the lawsuit against generic drug manufacturer Mutual Pharmaceutical Company.  When Karen visited her doctor complaining of shoulder pain, he prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions.  When Ms. Bartlett’s pharmacist filled the prescription, however, he gave her the generic version of the drug sulindac, rather than the brand-name drug.

Soon after taking the drug, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns on over 60-65 percent of her body.  For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma.  During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind.  Although she survived, she is severely disfigured, cannot eat normally due …

June 11, 2013 by Lisa Heinzerling
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Why does the White House take so long to review rules from the regulatory agencies?  As I have documented elsewhere, many rules have been stuck at the White House’s Office of Information and Regulatory Affairs (OIRA) for years.  Some of these remain there to this day.  What is the White House doing for the months and years that rules are stuck there?

One rule that just escaped from the clutches of regulatory review might provide a clue.  Just yesterday, EPA posted documents generated as a result of White House review of its rule on formaldehyde emissions from wood products.  These documents show at least one possible answer to the question of why review takes so long: perhaps it takes a very long time to make the benefits of regulation disappear!  This, at least, appears to be a primary consequence of the more-than-year-long tenure of the formaldehyde …

June 11, 2013 by Lisa Heinzerling
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The Obama Administration’s announcement that it will comply with a district court’s order that it make emergency contraceptives available to all women and girls without a prescription comes as a welcome development in a long-running administrative-law fiasco. But the Administration’s specific suggestions as to how it will set things right, set forth in letters sent yesterday to the district court and to the citizen petitioners who originally asked for nonprescription access to emergency contraceptives, are inadequate in several respects.

First, under the government’s approach, we will all have to wait for Teva Branded Pharmaceutical Products R&D, Inc. — the sponsor of the one-pill emergency contraceptive, Plan B One-Step — to submit a new application asking for full over-the-counter status for its product before anything can happen to implement the court’s ruling. The government’s letter to the court announcing its compliance with the court …

May 29, 2013 by Lisa Heinzerling
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Cross-posted on ACSBlog.

A panel of the Second Circuit Court of Appeals in New York has just taken under consideration the Food and Drug Administration’s motion for a stay of a district court order directing the agency to make levonorgestrel-based emergency contraceptives available to women and girls of any age without a prescription and without other point-of-sale restrictions. In deliberating on this motion, the panel of judges should not, I am sorry to say, take anything the FDA has said in its briefs at face value. The government’s opening and reply briefs on the motion to stay are so full of misstatements and omissions that the court could badly err if it did not take everything the government says with a shaker full of salt.

One of the factors in deciding whether to grant a stay pending appeal is the likelihood that the moving party …

March 12, 2013 by Thomas McGarity
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Next Tuesday, the Supreme Court will hear oral arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that raises once again the troubling question of whether federal regulatory agencies should trump local juries in common law tort actions.  The precise question at issue is whether the fact that the federal Food and Drug Administration (FDA) approved a name-brand drug many years ago precludes a state court jury from holding the manufacturer of the generic version of that drug strictly liable for damages to patients caused by marketing the drug. 

The plaintiff in this case, Karen Bartlett, visited her doctor in December 2004 complaining of shoulder pain.  Her doctor prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions.  When Ms. Bartlett’s pharmacist filled the prescription, however, it gave her the generic version of the drug …

Feb. 12, 2013 by Rena Steinzor
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This post was written by CPR President Rena Steinzor and Media Manager Ben Somberg.

The White House issued a fact sheet last Friday presenting “Examples of How the Sequester Would Impact Middle Class Families, Jobs and Economic Security.” The consequences of the impending budget cuts from the “sequester” are not some abstract problem; they’re serious dangers, like this one:

The Food and Drug Administration (FDA) could conduct 2,100 fewer inspections at domestic and foreign facilities that manufacture food products while USDA’s Food Safety and Inspection Service (FSIS) may have to furlough all employees for approximately two weeks. These reductions could increase the number and severity of safety incidents, and the public could suffer more foodborne illness, such as the recent salmonella in peanut butter outbreak and the E. coli illnesses linked to organic spinach, as well as cost the food and agriculture sector millions …

Feb. 6, 2013 by Lisa Heinzerling
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Eighty percent of the antibiotics used in this country are given not to humans, but to animals destined for the human food supply.  Most of these antibiotics are given to the animals not for the purpose of treating active infections, but for the purposes of promoting growth and preventing infection in the microbe-rich environment of the modern factory farm.  For over 40 years, the Food and Drug Administration (FDA) has been collecting evidence that this agricultural practice contributes to the development of antibiotic-resistant infections in the human population. Based on such evidence, in fact, the agency proposed to withdraw its prior approvals for two antibiotics used in animal feed due to the risks they posed to human health. The agency promised to hold hearings on the matter. That was over 35 years ago. On Friday, the future of this issue will be debated in oral arguments in …

Jan. 14, 2013 by Thomas McGarity
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When I teach my environmental law and food safety law students how to go about ascertaining the meaning of implementing regulations, I tell them to start with the sections of the regulations devoted to definitions and exemptions.  Quite frequently the most hard-fought controversies during the rulemaking process through which the agency promulgated the regulations were over the definitions and exemptions. 

That certainly seems to be true in the case of the long-awaited Food and Drug Administration’s (FDA) proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which the Obama Administration, with much fanfare, issued on January 4.  According to FDA’s analysis of the economic impact of the proposal, almost 80 percent of the country’s produce growers will not have to meet the standards because they are not covered in the definitions or are otherwise exempt.

The proposed rule, which …

Dec. 5, 2012 by Thomas McGarity
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The saga of the missing FDA food safety regulations continues with a new government filing in a lawsuit challenging FDA’s failure to promulgate regulations implementing three critical programs that Congress established in the Food Safety Modernization Act of 2011. 

As I noted in a previous posting, the three sets of regulations are currently bottled up in the White House Office of Information and Regulatory Affairs (OIRA), where they have gathered dust for a year. 

Well before the statutory deadlines, FDA sent OIRA proposed regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs, requiring growers to comply with “science-based” minimum sanitation standards, and for importers to verify that their products were produced under conditions that complied with FDA food safety requirements.  But the deadlines came and went while OIRA sat on the regulations to avoid criticism from …

Nov. 21, 2012 by Thomas McGarity
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One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act. 

Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out the obligations of growers, producers and importers of food.  Unfortunately, after almost two years, the regulations for the three most critical programs enacted by the new law have been written, but have not yet been promulgated.

On Thanksgiving Day, one set of implementing regulations will have been bottled up at the White House’s Office of Information and Regulatory Affairs (OIRA) for exactly one yearTwo other critical sets of regulations will pass the one-year milestone between Thanksgiving and December 9. 

Signed by President Obama in January 2011, the new …

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