Secrecy protects only laggards: why the FDA should disclose which drug companies volunteer for its “judicious use” policy for livestock antibiotics
The Food and Drug Administration (FDA) recently recommitted itself to its lame proposal to address the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics. Two documents issued last month reveal the details of the agency’s current plans. The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out “production uses” of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight. Production uses are aimed at promoting growth and improving feed efficiency, not at treating active infections. The FDA will continue to allow mass medication of whole herds and flocks of livestock for purposes of preventing infection.
The FDA has, in internal documents, conceded that “all” of the relevant drug companies must participate in order to make its approach work. But there is no guarantee that even a significant number of these companies will voluntarily give up production uses simply because the FDA asks them to. Even if some do – Zoetis and Elanco have said …
Has the U.S. "exported" its carbon emissions to China by relying on China to manufacture so many of our goods? There seems to be growing support for the idea that carbon emissions should be tied to consumption of goods rather than their manufacture, as the NY Times reported recently. There is a grain of truth to the idea. But consumer responsibility should be considered secondary. The primary responsibility rests with producers.
Most of the debate has been about climate change. But it may be easier to think through the issue in a less contentious context. Consider the problem of water pollution in the Mississippi River, which results in the infamous dead zone in the Gulf of Mexico. Agricultural runoff in the Midwest is a big part of the problem. A significant portion of the U.S. corn and soybean crops are exported to Asia.
Does this …
Some members of Congress apparently do not want agencies to regulate powerful agricultural and pharmaceutical interests in order to protect the public from dangerous risks. Yet, rather than say that — and be held accountable to the electorate for the consequences — they have developed what has become a standard, indeed almost boilerplate pretext to hide their endgame.
Specifically, they have drafted a provision snuck in as a rider to a farm bill that requires agencies to develop elaborate “high standards” for the use of science before they can regulate. Even more problematic than their obscurity is the fact that rather than deferring to the scientific community’s idea of what these high scientific standards should be, congressmen establish the rules of the game on their own. Given their politically-charged origins, it is thus not surprising that these congressionally developed rules are decidedly not in the public interest, nor …
Climate change and pollution affects everyone. Global warming-induced hurricanes pummel our coasts and droughts ravage our farmland. Our neighbors, friends, and children develop asthma and heart attacks because of air pollution and our favorite parks and hunting grounds are withering away.
The science is conclusive and polls reflect the concern of many Americans about global warming and its related pollution. So what can account for the lack of government action on the issue? The answer has a lot to do with our broken campaign finance system and the ability of individuals committed to denying the existence of climate change to dump huge amounts of money (much of it secret) into elections and in the political process.
During the 2012 election, outside spending groups, many of them newly created in the wake of the Supreme Court’s Citizens United decision, reported spending more than $1.28 billion to …
It’s like a Russian nesting doll of bad policy: House Republicans have contrived to take one of the most anti-science bills in memory and then place it inside one of the most anti-democratic legislative vehicles available. It’s part of an attempt to ram through into law new rulemaking requirements that would benefit the already-healthy bottom lines of their corporate benefactors at the devastating expense of the health, safety, pocketbooks, and perhaps even lives of the American public. That’s what is at stake with an obscure three-page rider—Section 12307, euphemistically entitled “Ensuring High Standards for Agency Use of Scientific Information”—in the 700-page House version of the Farm Bill (H.R. 2642, the Federal Agriculture Reform and Risk Management Act of 2013) that is currently undergoing conference committee consideration to resolve differences between it and the Senate version of the Farm Bill. (See page …
Many Senate Democrats try to paint themselves as defenders of working people. They rail against their colleagues who are “in the pockets of corporations and the rich.” But what they say, and what they do are two different things. This time, seven Democratic Senators are ready to screw poultry workers to please the owners of the poultry companies.
We’ve been writing for nearly two years on the USDA’s plan to “modernize poultry inspection” (e.g., here, here, here, here). It’s a plan that will give Tyson, Perdue, Pilgrims’ Pride and other poultry producers an additional $250 million a year in revenue. It will allow USDA to eliminate 800 inspectors, and it won’t improve, and could make worse, food safety. To “sell” poultry companies on the plan, USDA will allow them to increase line speeds up to 175 birds per minute.
The industry and …
Recently, the Administrative Conference of the United States (ACUS) adopted a statement on how to improve the “timeliness” of rule reviews by the White House Office of Information and Regulatory Affairs (OIRA). As regular readers know, OIRA has time and again delayed the release of crucial health, safety, and environmental regulations, leaving the public exposed to unnecessary dangers while these rules gather dust on OIRA’s desk—like the proposed rule on silica exposure that was delayed for over two and a half years.
Before discussing how ACUS addressed this issue, it’s worth considering what ACUS didn’t address. The project’s original title probably set expectations too high: “Improving the Timeliness, Transparency, and Effectiveness of OIRA Regulatory Review.” The stage appeared to be set for a broad examination of OIRA’s role, including its failure to meet the deadlines and disclosure requirements set forth in …
Recently, the Administrative Conference of the United States (ACUS) adopted a statement on how to improve the “timeliness” of rule reviews by the White House Office of Information and Regulatory Affairs (OIRA). As regular readers know, OIRA has time and again delayed the release of crucial health, safety, and environmental regulations, leaving the public exposed to unnecessary dangers while these rules gather dust on OIRA’s desk—like the proposed rule on silica exposure that was delayed for over two and a half years.
Before discussing how ACUS addressed this issue, it’s worth considering what ACUS didn’t address. The project’s original title probably set expectations too high: “Improving the Timeliness, Transparency, and Effectiveness of OIRA Regulatory Review.” The stage appeared to be set for a broad examination of OIRA’s role, including its failure to meet the deadlines and disclosure requirements set forth in …
Recently, the Administrative Conference of the United States (ACUS) adopted a statement on how to improve the “timeliness” of rule reviews by the White House Office of Information and Regulatory Affairs (OIRA). As regular readers know, OIRA has time and again delayed the release of crucial health, safety, and environmental regulations, leaving the public exposed to unnecessary dangers while these rules gather dust on OIRA’s desk—like the proposed rule on silica exposure that was delayed for over two and a half years.
Before discussing how ACUS addressed this issue, it’s worth considering what ACUS didn’t address. The project’s original title probably set expectations too high: “Improving the Timeliness, Transparency, and Effectiveness of OIRA Regulatory Review.” The stage appeared to be set for a broad examination of OIRA’s role, including its failure to meet the deadlines and disclosure requirements set forth in …
In 2001, a group of private citizens, public health groups, and medical organizations petitioned the Food and Drug Administration (FDA) to approve nonprescription status for the emergency contraceptive Plan B and its generic cousins. Under the Food, Drug, and Cosmetic Act, the FDA’s decision was supposed to turn on whether these drugs could be taken safely and efficaciously without the assistance of a licensed health professional. Instead, an investigation by the Government Accountability Office (GAO) and fact-finding by the district court handling litigation over the controversy made clear that the FDA bowed to political pressure, first by delaying any decision as long it could and then by being as stingy as possible in granting nonprescription access to emergency contraceptives.
Over a twelve-year period, the agency resorted to extreme measures to avoid answering the statutorily dictated question: whether women and girls could safely and efficaciously take emergency …
