Obama Expected to Sign FDA Bill into Law

Bill will address drug shortages & synthetic drugs


 
 

| Thursday, June 28, 2012


WASHINGTON (AP) — President Obama is expected to sign into law a mammoth bill passed by Congress Tuesday that reshapes how the Food and Drug Administration assures the safety of the drug supply, particularly imported medicines.

The bill is a must-pass piece of legislation because it extends the 20-year program that helps fund the FDA's budget for reviewing new drugs and medical implants. But lawmakers added dozens of provisions influencing FDA policies and the drug industry.

Here's a look at some of the key changes the bill would bring:

FOREIGN INSPECTIONS: Gives the FDA more leeway to inspect drug factories in China, India and other foreign countries. FDA has long been required to inspect U.S. manufacturing sites every two years, but most drug ingredients are now made overseas. The bill frees FDA inspectors to go after foreign drug plants.

COUNTERFEIT DRUGS: Hikes the maximum penalty for drug counterfeiting to $4 million or 20 years in prison. The current maximums are $10,000 or three years in prison. Drug counterfeiting has risen steadily over the past decade, and drugmakers reported more than 1,700 worldwide last year. The FDA is investigating two faked batches of the cancer drug Avastin that reached the U.S. this year from the Middle East by way of European supply chains.

FDA REVIEW FEES: Renews, through 2017, a program under which drugmakers pay the FDA to review new medications. For the first time, it also requires generic drugmakers to pay for reviews, adding $299 million in annual fees to the $693 million paid by makers of branded drugs. The bill also renews a similar program for reviews of medical devices.

BREAKTHROUGH DRUGS: Relaxes certain requirements — including allowing smaller and shorter clinical studies — to speed approval of drugs that appear to offer innovative treatments for life-threatening diseases.

OUTSIDE INSPECTORS: Allows drugmakers to hire non-government inspectors to assess whether factories are meeting U.S. quality standards. These inspections wouldn't take the place of the FDA's but could be used to bolster a company's safety record.

DRUG SHORTAGES: Requires drugmakers to notify the government at least six months before discontinuing production of a drug. More than 280 drugs are currently in short supply, creating life-threatening delays for patients with cancer and other serious diseases. The shortages are driven by factors including consolidation in the pharmaceutical industry.

SYNTHETIC DRUGS: Bans 28 chemicals used in synthetic drugs known as "bath salts" that are often sold at corner stores as hygiene products, incense or plant food and can trigger bizarre and violent behavior.



Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Connect: Have a thought or feedback about this? Add your comment now
Related Topics: News, FDA, drug shortages, President Obama, bath salts

What's Your Take? Comment Now ...

Featured Careers & Jobs in EMS





 

Get JEMS in Your Inbox

 

Fire EMS Blogs


Blogger Browser

Today's Featured Posts

 

EMS Airway Clinic

Simulation-Based Assessment Facilitates Learning & Enhances Clinical Judgment

Simulation is an educational tool that can be used to develop and refine clinical skills of the student in a controlled environment before they progress to becoming practicing clinicians.
More >

Multimedia Thumb

REMSA Programs Helps Reduce Hospital Visits

Community paramedic effort goes into service.
Watch It >


Multimedia Thumb

City Official Challenges San Francisco Fire Chief

Ambulance response times among problems noted by city supervisor.
Watch It >


Multimedia Thumb

Texas Ambulance Crash

Victoria ambulance collides with civilian vehicle.
Watch It >


Multimedia Thumb

Colorado Medics Ditch Pants for Kilts

“Real men do wear kilts.”
Watch It >


Multimedia Thumb

CO Leak at Illinois School

Girard incident sends over 130 to hospitals.
More >


Multimedia Thumb

Hands On September 2014

Who gets thumbs up this month?
More >


Multimedia Thumb

NYC Sept. 11 Anniversary

View images from the ceremony at Ground Zero.
More >


Multimedia Thumb

Braun Ambulances' EZ Door Forward

Helps to create a safer ambulance module.
Watch It >


Multimedia Thumb

Field Bridge Xpress ePCR on iPad, Android, Kindle Fire

Sneak peek of customizable run forms & more.
Watch It >


Multimedia Thumb

The AmbuBus®, Bus Stretcher Conversion Kit - EMS Today 2013

AmbuBus®, Bus Stretcher all-hazards preparedness & response tool
Watch It >


More Product Videos >