Analysts Mislead in Their Push to Weaken FDA's Produce Rule
In January of this year, the Food & Drug Administration proposed a rule on produce safety, as required by the 2011 Food Safety Modernization Act (FSMA). The rule would establish comprehensive standards designed to prevent foodborne illnesses linked to fruits, vegetables, and nuts—like the ongoing Cyclospora outbreak that has sickened 630 people so far, or the 159 cases of Hepatitis A caused by imported pomegranate seeds.
Sofie Miller and Cassidy West, two analysts from the George Washington University Regulatory Studies Center (RSC) recently filed a comment on the FDA’s proposal, recommending a number of changes that would leave gaping holes in the rule’s protections. (A little background: the RSC was founded in 2009 with an initial grant from the right-leaning, anti-regulation Searle Freedom Trust, although that fact is no longer disclosed on their website, nor do the commenters explain which—if any—stakeholders they represent.)
Probably because their analysis is not grounded in the real-world concerns of anyone actually affected by the rule, the RSC analysts tinker with its design as if they were bookkeepers balancing a ledger, rather than stopping to consider what those numbers really mean for public health. Applying rigid cost-benefit analysis, they seem …
More than 400 inspectors with the USDA’s Food Safety Inspection Service (FSIS) worked, on average, more than 120 hours each two-week pay period. Those were the findings of the agency’s Inspector General in an report issued late last month. Their investigation covered FY 2012, and included field work conducted from November 2012 through February 2013.
FSIS inspectors are assigned to more than 6,000 meat, poultry and egg processing plants in the U.S. They are responsible for ensuring that the product sold by companies to consumers is safe and wholesome. These firms process tens of billions of red meat and poultry annually. With some USDA inspectors working many hours of overtime—not just a couple hours per week, but an average of 20 extra hours each week—can their senses stay sharp and can they do their jobs effectively?
The IG mentioned that overworked …
Tomorrow, the new OIRA Administrator, Howard Shelanski, will testify before the House Small Business Committee on the results of the government-wide “look-back” at existing regulations. It will be an opportunity for the Committee’s Republicans to continue their assault on government programs that keep our food safe, air and water clean, and highways fit for travel. Shelanski could follow in his predecessor’s footsteps by trying to assuage the Republicans’ fears with glowing statistics about the allegedly huge savings that are expected to flow from revising some old regulations, or he could be more supportive of his fellow public servants and highlight the myriad programs that are working just fine and don’t need to be rolled back.
Food safety and occupational health advocates are hoping Shelanski will have an opportunity to give an update on a piece of the look-back program that falls somewhere between the …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
