FDA Seeking Gum Chewing Tester

    The Food and Drug Administration is seeking a small business to potentially supply the federal agency with a chewing gum tester.  Despite the frivolous sounding nature of the announcement, the search is a serious one, and apparently a growing need.  Chewing gum-based pharmaceuticals (such as nicotine gum) are already in use in the United States, and the FDA is looking for a way to measure the dosage and delivery (dissolution) of the medication in such products.
    The FDA is not looking for just any chewing gum tester, but the Erweka DRT-3 (or its equal), manufactured by Erweka, a German company that produces pharmaceutical and life-science testing equipment.  The DRT-3 can be seen in action here.
    According to the documents accompanying the notice, the FDA may be looking to establish a standard for testing chewing gum-based pharmaceuticals on the assumption that the gum-based method of drug delivery may become more widely used:

Currently, there is no official method (USP or FDA) to test medicated chewing gum products, and it is unclear for FDA reviewers on how to approve such drug products if similar applications are coming in the future...

The DRT-3 chewing gum dissolution tester will be evaluated and used to develop methods for drug release from commercial chewing gum products. The requested instrument will greatly enhance our dissolution testing efforts by evaluating new technology and validating testing methods. All these efforts will greatly support CDER’s NDA/ANDA review process on this special dosage form in the future.  

    The FDA has some very specific criteria in mind for its gum chewing tester, including:

• The angular displacement of the upper jaw shall be adjustable between 10° – 180°, movement frequency adjustable between 20 - 60 cycles per minute.
• Distance of upper and lower jaw in closed position adjustable -between 0-10 mm.
• Jaws shall be acid proofed stainless steel with blasted surface for a better grip.

There is no requirement that the machine must be able to walk and chew gum at the same time.


Note: A version of this article first appeared at The Weekly Standard.

FDA Seeks "Data Mining and Targeting Software"

    The Food and Drug Administration's Office of Criminal Investigations is soliciting bids for "Data Mining and Targeting Software" to help in its efforts to combat illegal trafficking in cigarettes and other tobacco products.  The announcement appeared Monday on the federal government's fbo.gov contracting website:

The Food and Drug Administration, Office of Criminal Investigations (OCI) was established in March 1992 by the Commissioner, with the urging of Congress, in response to concerns of increased criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and related acts. The mission of the OCI is to investigate suspected criminal violations of the FDCA; the Federal Anti-Tampering Act (FATA); and other statutes including applicable Title 18 violations; and to collect evidence to support successful prosecutive actions through the federal or state court systems, as appropriate. 

The FDA/OCI requires a data mining and targeting system for use in law enforcement operations to further ongoing efforts to counter the widespread illicit trafficking of FDA-regulated tobacco products throughout the United States. These products include misbranded, adulterated and counterfeit cigarettes and smokeless tobacco products. The data mining and targeting systems will have proprietary data analysis and extraction software that is utilized in the law enforcement community with user-defined data sets available and only accessible to law enforcement. The software allows users to search one, some, or all of the data sets at once, sort and analyze the data, and spin off new searches.

    The documents go on to say that the data will come from commercial sources and/or US Customs and Border Protection, and that initially the "system will be stand-alone but must be capable of being networked at a later date."


Note: This article first appeared at The Weekly Standard.

FDA: "Making Health and Health Care Equal for All"

    Liberals have long been accused of wanting to "level the playing field" by dragging everyone down to the same level rather than giving everyone equal opportunity by securing the rights to life, liberty and the pursuit of happiness.  A recent post on the website of the Food and Drug Administration (FDA) is only going to reinforce that notion.  The post is titled "Making Health and Health Care Equal for All" and explains the mission of the Office of Minority Health (OMH), established by the Affordable Care Act:

What exactly are health disparities? And how can they be reduced or eliminated? 

At the Food and Drug Administration (FDA), achieving equality in health and health care is part of the mission of the Office of Minority Health (OMH). The office was established in 2010 by the Affordable Care Act to help the agency address the needs of Americans who may be more vulnerable because of their race, ethnicity or other factors...

There can be many causes of health disparities, says [OMH Director Jonca Bull, M.D.]. They range from underlying genetics to socio-economic status, lack of insurance and lack of access to quality health care, including preventive care and follow-ups when a disease is diagnosed. And this can be complicated by limited English proficiency, which can affect the quality of a patient's interaction with a health care professional.

    The article lists several diseases and conditions that have higher rates of incidence among certain ethnic groups, and notes that "minority populations ... also have higher rates of obesity, asthma, preventable hospitalizations and infant deaths."

    So what is being done?

    FDA works in partnership with its counterparts in [Health and Human Services] but as a regulatory agency, its role is unique in bringing about changes that could help level the playing field when it comes to health and health care. 

Essentially, everything FDA's OMH does is related to fighting racial and ethnic health disparities[.]

    Again, talk of working to "level the playing field" and "fighting... disparities." But what about improving health?  Here are the four bullet points in the article:

• Enhancing diversity on FDA's scientific advisory committees is one area of focus, involving the recruitment of independent experts who have a scientific background in related health fields and expertise in the areas of minority health and health disparities. These advisory committees provide advice on health and science policy issues.
• In December 2012, the Summit on the Science of Eliminating Health Disparities attracted more than 4,500 people and featured more than 100 workshops. The summit was led by the National Institute on Minority Health and Health Disparities and co-sponsored by OMH and HHS. Highlights of the conference will be featured in a future publication on best practices for reducing health disparities on a broad scale.
• OMH works with health care professionals and patient advocates to increase minority representation in clinical trials of medical products.
• The office partners with universities to advance the study of, and research into, health disparities and the regulatory science that is the foundation of FDA's decisions.

    With the possible exception of the third point, none of these address actually improving the health or healthcare of anyone.  Even the third point ("increase minority representation in clinical trials of medical products") could be counterproductive if increasing minority representation skews the population sample away from one that reflects the population as a whole.

    Not until the very end of the article is there a statement about “ensuring the best health outcomes for all Americans.”  But from the very title of the article, it's a dubious assertion.  The FDA's aim is not equal access to good healthcare, but rather "Making Health and Health Care Equal for All."  If the focus is on increasing diversity and reducing disparities, the outcome is less likely to be the "best health outcomes for all Americans" and more likely to be the lowest common denominator for all.