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We will now complete our look at the "Right to Try Act of 2017". This week we will present:
- Investigational drugs for use by eligible patients-Exemptions
- Use of clinical outcomes
- Reporting
- Posting of information
- Liability
Investigational Drugs for Use by Eligible Patients-Exemptions
Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from specific sections of this Act provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces, or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in specific sections that apply to investigational drugs.
Use of Clinical Outcomes
Notwithstanding any other provision of this Act or specific others, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act unless-
- the Secretary makes a determination that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or
- the sponsor requests use of such outcomes.
Reporting
The manufacturer or sponsor of an eligible investigational drug shall submit to the Secretary an annual summary of any use of such drug under this section. The summary shall include:
- the number of doses supplied,
- the number of patients treated,
- the uses for which the drug was made available, and
- any known serious adverse events.
Posting of Information
The Secretary shall post an annual summary report of the use of this section on the Internet Website of the FDA.
Liability
With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to this section, no liability in a cause of action shall lie against-
- a sponsor or manufacturer; or
- a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law.
Determination Not to Provide Drug
No liability shall lie against a sponsor manufacturer, prescriber, dispenser, or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act.
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
Government and Industry Opioid System Fails
A Senate report describes systematic failures in the reporting system for suspicious opioid orders, faulting some drug distributors and manufacturers for their roles and criticizing the DEA for a year-long lull in enforcement actions.
The findings specifically involve disparities between two leading drug distributors: McKesson and AmerisourceBergen. The two distributors shipped nearly identical volumes of opioids to Missouri between 2012 and 2017: roughly 650 million doses each. However, the number of orders each company flagged as suspicious to authorities were nowhere close: 224 from AmerisourceBergen and 16,714 from McKesson.
https://www.statnews.com/2018/07/12/senate-report-opioids-distribution/
Chinese Contractor Making Over-the-counter Children's Drugs Issued Quality-control Warning Letter and Import Alert
The U.S. FDA has issued a warning letter to Foshan Jinxiong Technology, a contract manufacturer of over-the-counter drugs for children, citing four violations related to quality control.
The firm has been put on an import alert list since February, banning all of its products from entering the U.S. During the inspection, it was found that instead of testing each lot for identity and strength of the active ingredient prior to distribution, the company was asking clients to do the test after product release.
Also, the agency also found that Jinxiong failed to test incoming components sold to them, instead they relied only on certificates of analysis from unqualified sources.
https://www.fiercepharma.com/manufacturing/fda-slaps-warning-letter-chinese-contractor-making-otc-children-s-drug
Fluoroquinolone Antibiotics Label Warnings Strengthened on Risks of Mental Health and Hypoglycemic Adverse Reactions
The FDA is requiring safety labeling changes for the fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and make these warnings more consistent across the labeling for all fluoroquinolones administered orally or by injection.
The safety labeling changes are based on a comprehensive review of the FDA's adverse event reports and case reports published in medical literature.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm612995.htm
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Tip of the Week
Legitimate and fair competition pushes one to try harder. In sports, business, school, hobbies, we tend to do better when we are competing against someone. Also, there is usually something to be learned from your competitors that you can implement in your own life. Look at your own accomplishments and think of the competition you have had that helped get you to where you are now. |
