Biosimilars In Recently Passed Healthcare Bill

I was really surprised to find out that biosimilars are included in the recently passed healthcare bill, Patient Protection and Affordable Care Act.  I learned about this while reading Kevin O'Donnell's post on his blog (Where cooler heads prevail), "New U.S. Healthcare Bill Includes Pathway for Biosimilars and 12 Year Patent Exclusivity."

Kevin writes:

"This provision, Title VII- Providing Access to Innovative Medical Therapies, "prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date on which the reference product is first approved. In addition, it stipulates an additional 6 months of exclusivity for the use of reference products "in the pediatric population.""

References:
Full text of the Patient Protection and Affordable Care Act HR 3590

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FDA Controversy - Regen Biologic's Menaflex Device

The FDA is reassessing the safety of a device (Regen Biologic's Menaflex Device) that it previously approved for patients. The FDA conducted a March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting. Although the panel expressed that they would have liked to have seen more data on the device, they largely backed it as a safe and effective therapy.

The larger looming issue now is whether this will become precendent setting and raise the prospect of FDA re-evaluating previously approved devices.

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FDA Webinar on FDA Inspection Process

When:     Thursday, March 25, 2010, at 2 p.m. ET

Where:    https://collaboration.fda.gov/inspectionprocess/

Host:       FDA’s Office of Regulatory Affairs (ORA), 301-827-3101

             ORAContactUs@FDA.HHS.GOV

Speaker: Michael C. Rogers, deputy director, Office of Regional Operations

To ensure the safety of marketed products, FDA experts inspect domestic and foreign establishments, check shipments of imported products, and collect and test product samples for signs of contamination.

During this webinar, FDA experts will present information on

• the organization within FDA that is charged with conducting inspections
• the facilities FDA is responsible for inspecting
• what an inspection involves
• inspection follow-up and enforcement actions
• the rigorous training that inspectors receive

The presentation will run approximately 30 minutes and will include an opportunity to ask questions.

To join the webinar:

1. Click https://collaboration.fda.gov/inspectionprocess/ (or cut and paste it into your Internet browser)
2. Click "Enter as a Guest," fill in your name, then click "Enter Room"
3. Dial 1-877-685-5350 and enter participant passcode: 969082

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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New - FDA Orange Book

• Trusted FDA GMP online training programs and courses by SkillsPlus Intl Inc.

Updated May 26, 2022

The original link broke. You might also be interested in:

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - a webpage

---  the original post follows below  ---

It's here! The February 2010 supplement of the FDA's Orange Book, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS - 30th EDITION - Cumulative Supplement 02 - February 2010 (pdf).

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FDA Restricts Cigarette and Tobacco Sales and Distribution

I don't smoke, so I'm happy to see this action coming from the FDA, FDA Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco. The new rule becomes effective June 22, 2010, and has the force and effect of law.

Here are the highlights:

New Requirements Relating to Sale and Distribution

• Prohibits the sale of cigarettes or smokeless tobacco to people younger than 18.
• Prohibits the sale of cigarette packages with fewer than 20 cigarettes.
• Prohibits the sale of cigarettes and smokeless tobacco in vending machines, self-service displays, or other impersonal modes of sales, except in very limited situations.
• Prohibits free samples of cigarettes and limits distribution of smokeless tobacco products.

New Requirements Relating to Marketing (Labeling, Advertising, and Promotion)

• Prohibits tobacco brand name sponsorship of any athletic, musical, or other social or cultural event, or any team or entry in those events.
• Prohibits gifts or other items in exchange for buying cigarettes or smokeless tobacco products.
• Requires that audio ads use only words with no music or sound effects.
• Prohibits the sale or distribution of items, such as hats and tee shirts, with tobacco brands or logos.

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