Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, September 26, 2012
FDA Urged to Speed Approval of Drugs
LIFE & CULTURESeptember 25, 2012, 7:06 p.m. ET
By THOMAS M. BURTON
A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.
The President's Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called "special medical use" approvals.
The advisory report gave few details of what new laws or regulations might be required to limit a new drug's use to such populations. Historically, the FDA doesn't attempt to police how doctors use drugs, though companies' marketing is restricted to the conditions specified on the label.
To read the remainder of the article click here
Tuesday, September 25, 2012
Johnson City cancer center business manager pleads guilty to buying unapproved drugs
Updated September 19, 2012 8:41 PM
By Becky Campbell - Press Staff WriterRead more: http://www.johnsoncitypress.com/News/article.php?id=102462#ixzz27VZ118zG
Investigators say no proof unapproved drugs from McLeod were effective U.S. Attorney's office says with unapproved drugs "you don't know what you get"
By: NATE MORABITO | WJHL
Published: September 24, 2012
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JOHNSON CITY, Tenn. --
It's described as a scheme by top management at Mcleod Cancer and Blood Center to get foreign unapproved cancer drugs cheap, mingle them with FDA- approved ones and then hide the evidence from concerned nurses- ultimately giving the drugs to patients.
Tonight we have new information about the investigation.
McLeod’s former business manager Michael Dean Combs laid it all out last week. Combs pleaded guilty to receiving misbranded drugs in violation of the Food, Drug and Cosmetic Act.
It’s the result of a federal investigation centered around unapproved cancer drugs at clinics across the country.
We have team coverage tonight on the investigation, the future of the case and the potential impact on patients.
Combs is the first and only person to be charged locally so far.
Assistant U.S. Attorney Neil Smith wouldn't name any names, but did tell us "additional charges are anticipated."
To read the remainder of the article and see the video click here.
Coping With Critical Drug Shortages
Drug Shortages and Clinicians: No Time for ComplacencyComment on “Coping With Critical Drug Shortages"
Paula A. Rochon, MD, MPH; Jerry H. Gurwitz, MD
Arch Intern Med. Published online September 24, 2012. doi:10.1001/2013
Published online September 2012
To read the article click here.
Monday, September 24, 2012
New York Times Article: At the Track, Racing Economics Collide With Veterinarians’ Oath
Horse-racing veterinarians are both doctor and
drugstore; the more drugs they prescribe, the more money they make. To read article click here http://www.nytimes.com/2012/09/22/us/at-the-track-racing-economics-collide-with-veterinarians-oath.html?smid=pl-share
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