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We are continuing our look at the Right to Try Act of 2017. This week, we will present the definitions of important terms/phrases in the Act.
Definitions
Biological Product: has the meaning given to such term in section 351 of the Public Health Service Act. (Summary: Biological products are regulated by the FDA and are used to diagnose, prevent, treat, and cure diseases and medical conditions. Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.)
Device, Drug: have the meanings given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). (Summary: means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Eligible Patient: means a patient
- that has been diagnosed with a life-threatening disease or condition as defined;
- who has exhausted approved treatment options, and
- is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who,
- is in good standing with the physician's licensing organization or board; and
- will not be compensated directly by the manufacturer for so certifying; and
- who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent.
Eligible Investigational Drug: means an investigational drug (as such term is used in section 561)-
- for which a Phase 1 clinical trial has been completed;
- that has not been approved or licensed for any use under section 505 of this Act or section 351 of the public Health Service Act;
- for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or
- that is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and
- is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and
- the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i).
Experimental Drug, Biological Product, or Device: The term ''experimental drug, biological product, or device'' that-(A) has successfully completed a phase 1 clinical investigation; (B) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (C) is not approved, licensed, or cleared for commercial distribution.
Phase 1 Clinical Investigation: means a phase 1 clinical investigation of a drug, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).
Terminal Illness: has the meaning given to such term in the State law specified in subsection (a)(1)(B).
More coming next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
Mylan Plant Receives 32-page FDA Form 483
3,500 job cuts at Mylan's Morgantown, West Virginia plant were preceded by a 32-page Form 483 at the plant. The agency in 13 observations chastised senior management for poor oversight by the plant's quality-control department, major lapses in equipment cleaning, ineffective laboratory controls and sampling, and more. When it announced the cuts at the 3,500 employee plant, Mylan had said "We've realized that our Morgantown plant needed to be right-sized to be less complex." The company also said it is committed to maintaining its U.S. manufacturing footprint and plans to "continue making the majority of the medicines we supply to the U.S in the U.S."
https://www.fiercepharma.com/manufacturing/mylan-plant-slapped-32-page-fda-form-483
FDA Approves Sweaty Armpits Treatment
A topical cloth for sweaty armpits has been approved by the FDA, giving patients an easy remedy for an often anxiety-provoking condition. Dermira announced that its medication Qbrexza is the first of its kind to be approved by the FDA to reduce excessive underarm sweating. The drug will be administered in a wipe that can be rubbed over the skin daily to block sweat glands from activating. It will be available for sale in October. About 15.3 million people in the U.S. struggle with excessive sweating, but only one in four seek medical interventions. In one study, 53 percent of patients said Qbrexza reduced sweat production by roughly half, versus 28 percent in a comparison group using a non-medicated cloth, the drug company reported.
http://www.newsweek.com/fda-approves-cure-sweat-armpits-1002788
More Lawsuits Filed Against Manufacturer Accused of Selling Contaminated Medicines
Lawsuits continue to mount against a South Florida pharmaceutical manufacturer accused of distributing contaminated drugs. PharmaTech LLC, along with its principals and distributors of its products, are now subjects of seven lawsuits on behalf of patients said to have been sickened or killed, including three infants who reportedly died after being given a liquid stool softener made by the company. The company vacated its Davie plant in June 2017 after inspection reports by the FDA in August 2016 and May 2017 identified numerous quality-control deficiencies in its manufacturing processes. The 2016 inspections came on the heels of a voluntary recall by the company of the stool softener, liquid docusate, that the FDA and the Centers for Disease Control and Prevention said affected 63 people in 45 states. FDA testing identified a water-borne bacteria in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, as well as in the water system used to make the product.
http://www.sun-sentinel.com/business/fl-bz-pharmatech-lawsuit-update-20180627-story.html
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