Homeopathy May Receive Heightened Scrutiny From Regulatory Agencies

While it appears (at least to me) to get more attention (and ridicule).  Homeopathy – the attempt to treat conditions with items that produce the same symptoms in healthy patients – is a business of note in the U.S.  While the Food and Drug Administration (FDA) regulates homeopathic treatments, it does not make claims as to their efficacy.

(Let’s put aside the discussion of what reason there might be to regulate a substance without judging whether it does what it is claimed to do.)

That might change soon.  According to Dan Vergano at Buzzfeed, both the FDA and the Federal Trade Commission (FTC) may act soon on homeopathic treatments.  The FTC has raised concerns that FDA practice in this area runs counter to the FTC requirement that health claims in advertising need to be backed up by “competent and reliable scientific evidence.”

This has, apparently, been a longstanding conflict, as the FDA first promised to put homeopathic products up to a standard comparable to the FTC’s in 1972.  Maybe, just maybe, this long standoff is approaching an end.

PCAST Wants People To Hear Better For Less

On Monday the President’s Council of Advisors on Science and Technology (PCAST) released a letter report on innovation in hearing technologies.  The focus of the report is on the technologies used for mild and/or moderate hearing impairment.  The aging population will have need of such technologies, but a relatively small percentage of people who could benefit from them actually use them.  To help support the report recommendations, PCAST makes the argument that the current market and regulations covering hearing aids lead to a relatively static market that provides little innovation and extracts rather large costs for devices, preventing many from purchasing them.

The recommendations are exclusively about regulations.  PCAST recommends that non-surgical air conductive hearing aids be allowed for over-the-counter sales without needing to visit a credentialed dispenser.  Similarly, the report recommends that diagnostic tests for fitting and adjusting these devices should be available over the counter.  PCAST wants the Food and Drug Administration to withdraw its 2013 draft guidance on personal sound amplification devices (PSAP), which, in the opinion of PCAST, heightens an artificial distinction between the two kinds of devices that prevents those with hearing loss to benefit from advances in technology.

(While the report does not address this head on, the distinction between hearing aids and PSAP devices touches on the different values placed on technology that restores ‘normal’ function and technology that ‘augments’ that function.  Possibly a topic more appropriate for the Bioethics Commission.)

The other two recommendations call for consumers to have the ability to take the results of relevant hearing and audio tests acquired from hearing aid dispensers and audiologists at no additional cost.  This would be comparable to what consumers can already do with vision tests for eyeglasses and/or contact lenses.

The date of the next PCAST meeting is November 20, though it is not currently on the PCAST website.  This letter report will be on the agenda, along with presentations on nanotechnology and new regulatory frameworks for research.   The PCAST study on private sector activities in climate change adaptation and resilience.  More details will be available once the draft agenda is online.

Tell The Government How To Update Its Biotechnology Regulations

Back in July the Office of Science and Technology Policy (OSTP) announced that it would be leading an interagency effort to review and update the Coordinated Framework for the Regulation of Biotechnology (Framework). Part of the effort would include soliciting public input on both updates to the Framework and the development of a long-term strategy for dealing with emerging biotechnologies.

Last week the OSTP published a Request for Information (RFI) in the Federal Register seeking that public input.  The submission deadline is 5 pm Eastern time, November 13.

Here are the questions listed in the RFI (the product areas and agency roles are summarized in the RFI and available in the Background section of the memorandum sent to agencies on this effort):

  1. What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?
  2. What additional clarification could be provided regarding the roles that each agency plays for different biotechnology product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment?
  3. How can Federal agencies improve their communication to consumers, industry, and other stakeholders regarding the authorities, practices, and bases for decision-making used to ensure the safety of the products of biotechnology?
  4. Are there relevant data and information, including case studies, that can inform the update to the CF [Coordinated Framework] or the development of the long-term strategy regarding how to improve the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?
  5. Are there specific issues that should be addressed in the update of the CF or in the long-term strategy in order to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?

While submissions can be submitted by regular mail, electronic submission is preferred.  Please see the Federal Register notice for additional information.

Petitions And GMO Labeling – Waiting For The FDA

One of the petition responses released this summer from the Obama Administration concerned the mandatory labeling of food containing genetically modified organisms (GMOs).  I want to emphasize the mandatory part of the last sentence, as the Administration’s response emphasized the voluntary labeling that presently exists.

The Administration’s response also deferred to the Food and Drug Administration (FDA), which is presently considering two petitions about mandatory labeling for food containing GMOs.  As best as I can tell, no final decision has been made in the 10 weeks since the Administration released its petition response in late July.

The Administration also deferred to the FDA and other agencies concerning the ongoing effort to update federal regulations on biotechnology.  As I posted in July, that process has just started, so the Administration’s response, while seemingly supportive of the concerns over making sure consumers know what food is produced without GMOs, the policy actions have not (yet) supported that sentiment.

White House Launches Effort To Revise Biotechnology Regulation

While I find the timing suspect, on Thursday John Holdren, Director of the White House Office of Science and Technology Policy (OSTP), announced (along with other senior White House staff) the Administration will be reviewing the Coordinated Framework for the Regulation of Biotechnology, the policy that designates agency responsibilities for overseeing the introduction of biotechnology products into the environment (H/T Grist).  First developed in 1986, the last revision was in 1992.  So, clearly overdue.

Holdren’s announcement accompanied a memorandum to the Environmental Protection Agency, the Department of Agriculture and the Food and Drug Administration.  It (along with Holdren’s blog post) outlines the elements of the review process:

  • Updating the Common Framework (with public input) to clarify the biotechnology product areas (not processes) for which each agency will be responsible.  This will include how to handle situations where more than one agency may be responsible.
  • Developing a long-term strategy (with public input) to ensure that the Federal regulatory process will be better prepared for emerging biotechnologies.  This would include horizon scanning exercises and additional support of so-called ‘regulatory science.’
  • An independent examination of the future landscape of biotechnology.  The National Academies have already been engaged to start this analysis.

This all sounds great, but there are some aspects of this that give me pause.  First, the announcement comes the afternoon before the July Fourth holiday weekend.  It screams news dump – an effort to ensure that very few people become aware of the effort.

Additionally, while the revisions and the strategy will involve public input, Holdren asks for people interested in additional information to register.  If this wasn’t already part of an announcement that seems timed to minimize public reception, I might not think much of it.  But I can see the Administration limiting its subsequent publicity on this project to the people who register.  If they are going to try and hold listening sessions around the country (the first one will take place this fall), I think they should spread their message far and wide.

Finally, I guess I’m still a bit chagrined from other efforts to revise (or develop) regulations related to science and technology research.  The effort to revise the Common Rule related to human subjects research stalled out after a big public comment push in 2011.  And it still seems as though the push on scientific integrity policies has failed mainly from a lack of coordinated follow-through from the OSTP.

I’d love to see this not happen with the revisions to the Coordinated Framework, but I’m not optimistic – especially with roughly 18 months to go with this Administration.

U.S. Government Not Keen On Germ-Line Editing, At Least Right Now

Yesterday John Holdren, Director of the Office of Science and Technology Policy (OSTP), posted to the OSTP blog about recent activities in genome editing.  While the Chinese effort to conduct genome editing in human embryos attracted headlines and an announcement from the National Institutes of Health stating it would not fund similar research, it was not the specific focus of the statement.

That was reserved for the recent announcement that the National Academy of Sciences and the National Academy of Medicine (the new name of the Institute of Medicine) launched an initiative to address these technologies.  The initiative will include an international meeting this fall, along with a committee to study gene-editing technologies and an advisory board to guide the effort.  The project will include, technical, social, legal and ethical issues related to these technologies.

Dr. Holdren’s blog post and the Academies’ announcement noted the historical precedents for this kind of a priori assessment, including the restrictions imposed on recombinant DNA research, gain-of-function research, stem cell research and human cloning while researchers and policymakers discussed the implications of that work.

While not going so far as to echo calls for a moratorium on germline genetic editing, Dr. Holdren’s blog post can be read to imply Administration support for such a move.

“The White House applauds NAS and NAM for convening this dialogue and fully supports a robust review of the ethical issues associated with using gene-editing technology to alter the human germline. The Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.”

Given the nature of how the National Academies typically prepare their study committees, the international meeting this fall will more likely be the start of its process rather than a culmination.  I would also not be surprised to see the Presidential Commission for the Study of Bioethical Issues engage with these technologies, either through its own initiative or a request from the President.

If You’re Too Lazy To Drink Your Alcohol

Last year I posted about Palcohol, a powdered alcohol that was approved by the Alcohol and Tobacco Tax and Trade Board, but that approval was short-lived due to problems with the product labels.

Proper approval came through yesterday, making it legal to sell Palcohol in the United States.  The manufacturer has taken pains on the website to assure people that the product cannot be abused (not that people won’t try).  That the size and volume of the product necessary for spiking beverages, getting drunk and or smuggling it is too much to make it a practical method of abuse.

I am intrigued by the purported beneficial uses of the product that aren’t just making it lighter and easier to pack alcohol.  An ‘industrial formulation’ of the product could allow for easier forms of antiseptic, fuel, and other non-consumable applications for alcohol.

However, the industrial formula was not the one approved for sale.  The flavored versions of powdered alcohol have attracted the attention of several state legislatures, which are working on banning the sale of powdered alcohol.  Two states, Alaska and Delaware, already have laws on the books that cover powdered alcohol (for human consumption).

So, unless your state works to ban the product by the summer, you should be able to get your powdered drink on later this year.