Dangerous Imports and Drugs » drug marketing http://toyota-acceleration.com/blog Sun, 15 May 2011 23:43:40 +0000 en hourly 1 http://wordpress.org/?v=3.0.4 FDA stops firm marketing unapproved cold medicines http://toyota-acceleration.com/blog/2009/04/fda-stops-firm-marketing-unapproved-cold-medicines.html http://toyota-acceleration.com/blog/2009/04/fda-stops-firm-marketing-unapproved-cold-medicines.html#comments Fri, 10 Apr 2009 13:20:00 +0000 Gordon Johnson http://toyota-acceleration.com/blog/2009/04/fda-stops-firm-marketing-unapproved-cold-medicines.html Date: 4/10/2009

WASHINGTON (AP) — Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Friday that East Windsor, N.J.-based Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Neilgen, which also does business as Unigen Pharmaceuticals, is based in Westminster, Md.

“Consumers in possession of these products should discontinue using them and discuss FDA-approved treatments with their health care professional,” the FDA said in a statement.

Company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.

Company leaders did not immediately respond to calls for comment Friday afternoon.

Friday’s action comes the same week the FDA ordered a number of medical device manufacturers to submit data on products that were never approved. The devices, which range from pacemaker generators to dental implants, were released to market before the 1976 law which gave FDA authority to regulate new devices.

Copyright 2009 The Associated Press.

]]> http://toyota-acceleration.com/blog/2009/04/fda-stops-firm-marketing-unapproved-cold-medicines.html/feed 0 Pfizer completes part of painkiller settlement http://toyota-acceleration.com/blog/2008/10/pfizer-completes-part-of-painkiller-settlement.html http://toyota-acceleration.com/blog/2008/10/pfizer-completes-part-of-painkiller-settlement.html#comments Thu, 23 Oct 2008 11:22:00 +0000 Gordon Johnson http://toyota-acceleration.com/blog/2008/10/pfizer-completes-part-of-painkiller-settlement.html

Date: 10/22/2008

NEW YORK (AP) _ Pfizer Inc. said Wednesday it finalized part of a larger, $894 million deal to settle lawsuits over its promotion of the painkillers Celebrex and discontinued Bextra.

The company made official a deal that would pay $60 million to settle investigations by 33 states and Washington, D.C., over Bextra, while also agreeing to adopt compliance measures. Various states alleged Pfizer promoted the painkiller for “off-label” uses, or uses it was not approved for. While a physician is allowed to prescribe drugs for off-label uses, a company cannot market them for unapproved uses.

States also alleged the company misrepresented the safety of the drug.

As part of the settlement, Pfizer denied that its promotional practices violated any laws.

Among other strictures, the settlement requires Pfizer to submit all consumer television advertisements to the FDA for approval, the New Jersey attorney general’s office said. Pfizer said such practice was already company policy.

Last week, the company said it would pay $745 million to settle personal injury cases, $60 million to cover settlements with attorneys general in the 33 states and Washington, D.C., and $89 million to cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

In all, the company said the settlements would cover more than 90 percent of the pending legal actions.

“As we announced last week, these settlements avoid the disruption and expense of litigation and put these matters behind us,” Amy W. Schulman, senior vice president and general counsel of Pfizer, said in a statement.

Celebrex and Bextra came under scrutiny following lawsuits over a similar drug made by Merck & Co., called Vioxx. Merck has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming the drug caused heart attacks, ischemic strokes or death.

Bextra, like Vioxx, was a Cox-2 inhibitor.

“This medicine (Bextra) was rigorously studied and tested by the company and independent medical experts, and information about its benefits and risks was fully disclosed to the FDA,” Schulman said.

Celebrex is currently the only Cox-2 inhibitor on the market.

Pfizer has also agreed to other compliance measures regarding its promotional programs. The New Jersey Attorney General’s office, in a statement, said the settlement places strictures on such practices as companies “ghost writing” drug-related articles and studies, deceptively using scientific data when marketing to doctors, and awarding incentives to sales staff to increase off-label prescribing by doctors.

“This case should send a strong message to the industry at large that New Jersey does not tolerate deception and misleading claims in the promotion of prescription drugs,” Attorney General Anne Milgram said in a statement.

Copyright 2008 The Associated Press.

]]> http://toyota-acceleration.com/blog/2008/10/pfizer-completes-part-of-painkiller-settlement.html/feed 0