Food And Drug Administration 's Proposal Research Articles

FDA's proposed rule for the regulation of laboratory-developed tests.

In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), including modified FDA-approved/cleared tests. We outline here concerns from the clinical and public health microbiology laboratory perspective. It is our opinion that LDTs performed by individual Clinical Laboratory Improvement Amendments-certified diagnostic laboratories should not be regulated in the same way as commercial IVDs. This rule, if finalized, will negatively impact the diagnostic services currently offered by clinical and public health laboratories and, therefore, patients and the providers who care for them. Ending enforcement discretion will likely stifle diagnostic innovation and decrease access to diagnostic testing and health equity. Furthermore, the lack of infrastructure, including personnel and funding, at the FDA and diagnostic laboratories to support the required submissions for review is an obstacle. Like the FDA, diagnostic laboratories prioritize patient safety, accurate clinical diagnostics, and health equity. Since the scope of the LDT landscape is currently unknown, we are supportive of a registration process, along with non-burdensome adverse event reporting, to first understand the scope of clinical use of LDTs and any associated safety concerns. Any regulatory rule should be based on data that have been gathered systematically, not anecdotes or case reports. A rule must also balance the potential negative impact to patient care with realistic safety risks for infectious disease diagnostics.

Test anxiety

Test anxiety

The FDA and genetic testing: improper tools for a difficult problem.

The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.

Antibiotics: Call for Real Change

![Figure][1] CREDIT: ALVAREZ/ISTOCKPHOTO (MODIFIED BY G. GRULLON/ SCIENCE ) In his Editorial “Time to Deal with Antibiotics” (15 November 2013, p. [777][2]), D. Kennedy mentioned our assessment of the impact of the Pew Commission on Industrial Farm Animal Production (IFAP) ([ 1 ][3]). We support his call to end the misuse of antibiotics in animal agriculture. We believe, however, that finalization of the U.S. Food and Drug Administration (FDA) guidance documents will not have a meaningful impact on the way these life-saving drugs are administered to animals; thus, they will not slow the contribution of IFAP to our rapid progression toward a postantibiotic era. These guidances—nonbinding pleas for the cooperation of drug companies—do not call for an end to the use of antimicrobials in the absence of a microbial disease or documented disease exposure, as recommended by the Commission ([ 2 ][4]). Instead, they would effectively rebrand uses currently labeled “growth promotion” as “disease prevention.” Like growth promotion, prophylactic uses entail low, subtherapeutic doses and can span much of the animal's life span. They apply continuous selective pressure for antibiotic resistance and may even induce new resistance-conferring mutations ([ 3 ][5]). Furthermore, the FDA's proposal for veterinary oversight would eliminate the federal requirement that a valid “veterinarian-client-patient relationship” exist before veterinarians order the use of antibiotics in feed, allowing veterinarians to prescribe antibiotics for use at operations they have not visited recently for administration to animals they have never seen. The head of a large drug company recently told The Wall Street Journal that the guidances will not substantially affect revenues ([ 4 ][6]), implying that minimal changes to antibiotic sales are expected. This explains why companies support voluntary limits on their products: The limits will have little practical effect. We share Kennedy's assessment of the problem, but instead would call for meaningful regulation—comparable to what he attempted as FDA commissioner almost four decades ago—to curb irresponsible antibiotic use. If such efforts fall short, legislative relief is needed. 1. [↵][7] Johns Hopkins Center for a Livable Future, Industrial Food Animal Production in America: Examining the Impact of the Pew Commission's Priority Recommendations (Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 2013); [www.jhsph.edu/research/centers-and-institutes/johns-hopkins-center-for-a-livable-future/\_pdf/research/clf\_reports/CLF-PEW-for%20Web.pdf][8]. 2. [↵][9] Pew Commission on Industrial Farm Animal Production, Putting Meat on the Table: Industrial Farm Animal Production in America (Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 2008); [www.ncifap.org/_images/PCIFAPFin.pdf][10]. 3. [↵][11] 1. D. C. Love, 2. M. F. Davis, 3. A. Bassett, 4. A. Gunther, 5. K. E. Nachman , Environ. Health Perspect. 119, 279 (2011). [OpenUrl][12][PubMed][13][Web of Science][14] 4. [↵][15] 1. P. Loftus , Zoetis chief leads animal-health firm following split from Pfizer, Wall Street Journal (2013); [1]: pending:yes [2]: /lookup/doi/10.1126/science.1248056 [3]: #ref-1 [4]: #ref-2 [5]: #ref-3 [6]: #ref-4 [7]: #xref-ref-1-1 View reference 1 in text [8]: http://www.jhsph.edu/research/centers-and-institutes/johns-hopkins-center-for-a-livable-future/_pdf/research/clf_reports/CLF-PEW-for%20Web.pdf [9]: #xref-ref-2-1 View reference 2 in text [10]: http://www.ncifap.org/_images/PCIFAPFin.pdf [11]: #xref-ref-3-1 View reference 3 in text [12]: {openurl}?query=rft.jtitle%253DEnvironmental%2BHealth%2BPerspectives%26rft.stitle%253DEnvironmental%2BHealth%2BPerspectives%26rft.aulast%253DLove%26rft.auinit1%253DD.%2BC.%26rft.volume%253D119%26rft.issue%253D3%26rft.spage%253D279%26rft.epage%253D283%26rft.atitle%253DDose%2Bimprecision%2Band%2Bresistance%253A%2Bfree-choice%2Bmedicated%2Bfeeds%2Bin%2Bindustrial%2Bfood%2Banimal%2Bproduction%2Bin%2Bthe%2BUnited%2BStates.%26rft_id%253Dinfo%253Apmid%252F21030337%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [13]: /lookup/external-ref?access_num=21030337&link_type=MED&atom=%2Fsci%2F343%2F6167%2F136.1.atom [14]: /lookup/external-ref?access_num=000287926700013&link_type=ISI [15]: #xref-ref-4-1 View reference 4 in text

Curtailing antibiotic use in agriculture: it is time for action: this use contributes to bacterial resistance in humans.

Curtailing antibiotic use in agriculture: it is time for action: this use contributes to bacterial resistance in humans.

Projection of Tentative Expiry Date from One-Point Accelerated Stability Testing II. Overage Consideration

AbstractA previous publication (1) analyzed a statement originated from the Food and Drug Administration (FDA) that a drug product which is stable for three months at 37–40° and 75% or higher relative humidity can be given a tentative expiry period of two years from the date of manufacture. Conditions which can be uesd to make a successful projection using such a proposal have been established. These conditions are applicable only to pharmaceutical systems which do not contain an overage. The theoretical discussion is extended in this communication to analyze the effect of the overage on the proposed projection of the expiry period. The analysis shows that the inclusion of the overage lowers the threshold activation energy needed to satisfy the FDA's proposal

Projection Op Tentative Expiry Date Prom One-Point Accelerated Stability Testing

AbstractThe Food and Drug Administration (FDA) is proposing that a satisfactory three-month stability testing of a drug product at 37 to 40 °C and 75% or higher relative humidity can be employed to project a tentative expiry date of two years from the date of manufacture. This proposal is theoretically analyzed and its limitation is established. A successful projection of the expiry date according to FDA's proposal depends on the drug level at the end of the accelerated stability testing, the activation energy, and the temperature of the accelerated condition and the normal storage condition. The applicability of this method in assessing the stability characteristics of pharmaceutical formulations in the development process is discussed.