Under the Obama administration, the FDA has opted not to crack down on compounding pharmacies that are mass-producing cheaper drugs under less scrutiny than heavily regulated pharmaceuticals as part of a push to reduce health costs, a former top Bush-era FDA official told the Herald.
The administration made the decision that having access to cheap drugs is more important than the assurances of safety and efficacy from the FDA, said Sheldon Bradshaw, the FDAs senior legal counsel in the George W. Bush administration who now works as a Washington lawyer representing corporations regulated by the FDA.
The practices of one compounding pharmacy, Framingham-based New England Compounding Center, are now under federal and state investigation after the companys steroid injections for back pain were linked to the nationwide fungal meningitis outbreak that reportedly has sickened 119 and killed 11 people.
Bradshaw said the administrations demand for cheap drugs was reflected in the FDAs decision in 2011 not to go after cheaper compounded versions of the premature birth prevention drug Makena, manufactured by KV Pharmaceuticals, which subsequently sued the FDA and lost.
That act has emboldened pharmacy compounders and as a direct result, pharmacy compounders for the last year and a half have thought they could compound with impunity copies of FDA-approved drug products, Bradshaw said.
Boston University law professor Kevin Outterson noted compounding pharmacies were relieved of some regulation in 2002, when the U.S. Supreme Court struck down a law regulating them because of a provision that banned them from advertising. Outterson said Congress failed to amend the law.
It could have been fixed a decade ago, Outterson said.
U.S. Rep. Edward J. Markey yesterday said he intends to address the oversight issues surrounding compounding pharmacies.
It is a regulatory black hole, Markey told the Herald. I think it is shocking the magnitude of the sales by one company across the United States without FDA regulation 17,000 across various states. Thats impossible for an individual state to regulate.
FDA spokeswoman Erica Jefferson said the agency tries to ensure drugs are high-quality, safe and effective.
Continue reading here:
Critics: Obama shares outbreak blame
- Diazepam dosage - Video - April 8th, 2012 [April 8th, 2012]
- Cardura XL - Video - April 8th, 2012 [April 8th, 2012]
- Actonel 35 mg - Video - April 8th, 2012 [April 8th, 2012]
- Spiriva HandiHaler - Video - April 8th, 2012 [April 8th, 2012]
- Paxil withdrawal - Video - April 8th, 2012 [April 8th, 2012]
- Nizoral cream - Video - April 8th, 2012 [April 8th, 2012]
- Cytotec aborto - Video - April 8th, 2012 [April 8th, 2012]
- Plavix 75 - Video - April 8th, 2012 [April 8th, 2012]
- Generic Latisse - Video - April 8th, 2012 [April 8th, 2012]
- Ciprofloxacin Hcl 500mg - Video - April 8th, 2012 [April 8th, 2012]
- Arcoxia 120 mg - Video - April 8th, 2012 [April 8th, 2012]
- Generic Pharmacy from Leaderpills.com - Video - April 8th, 2012 [April 8th, 2012]
- albuterol aerosol inhaler - Video - April 8th, 2012 [April 8th, 2012]
- albuterol adverse effects - Video - April 8th, 2012 [April 8th, 2012]
- lumigan price - Video - April 8th, 2012 [April 8th, 2012]
- lumigan eyelashes - Video - April 8th, 2012 [April 8th, 2012]
- lumigan eyelash treatment - Video - April 8th, 2012 [April 8th, 2012]
- lumigan eye drops - Video - April 8th, 2012 [April 8th, 2012]
- Operation: RX Drug Hunt - May 7th, 2012 [May 7th, 2012]
- Poptent's amateurs sell cheap commercials to big brands - May 9th, 2012 [May 9th, 2012]
- Pharmacist sees bright future for Benevere specialty practice - May 12th, 2012 [May 12th, 2012]
- Globales Kompetenzzentrum für Windkraft in Dänemark - May 15th, 2012 [May 15th, 2012]
- Unsicherheit prägt Plast 2012 in Mailand - May 18th, 2012 [May 18th, 2012]
- Boots' move described as 'subsidisation' - May 30th, 2012 [May 30th, 2012]
- Small Business Owners Confident Despite Economy - June 9th, 2012 [June 9th, 2012]
- Minnesota Sounds and Voices: Salah Fattah and the Egyptian music of Amwaaj - June 11th, 2012 [June 11th, 2012]
- 5 Men’s Health Tests to Save Your Money and Your Life - June 12th, 2012 [June 12th, 2012]
- A Cheap Alternative to the Dollar Stores - June 13th, 2012 [June 13th, 2012]
- South Africa: Destined to Live and Die in Pain - June 15th, 2012 [June 15th, 2012]
- Destined to live and die in pain - June 15th, 2012 [June 15th, 2012]
- India's cheap drugs under threat - September 30th, 2012 [September 30th, 2012]
- Don't Over Analyze, This Stock is Too Cheap - October 5th, 2012 [October 5th, 2012]
- Dated drugs in state hospital - October 6th, 2012 [October 6th, 2012]
- Debbie's Deals: Flu shots - October 17th, 2012 [October 17th, 2012]
- Cialis buy cheap - November 1st, 2012 [November 1st, 2012]
- Ski Jump Part 1 - Video - November 1st, 2012 [November 1st, 2012]
- Generic Viagra Online - Video - November 1st, 2012 [November 1st, 2012]
- Generic Viagra.flv - Video - November 1st, 2012 [November 1st, 2012]
- Generic viagra kamagra - Video - November 1st, 2012 [November 1st, 2012]
- Cheap Generic Viagra Online - Video - November 1st, 2012 [November 1st, 2012]
- viagra cheap pharmacy iframe - Video - November 10th, 2012 [November 10th, 2012]