Dangerous Imports and Drugs » drug manufacturers

FDA stops firm marketing unapproved cold medicines

Gordon Johnson — Fri, 10 Apr 2009 13:20:00 +0000

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.

Report: FDA officials opposed drug suit policy

Gordon Johnson — Thu, 30 Oct 2008 00:59:00 +0000

Date: 10/29/2008

By KEVIN FREKING
Associated Press Writer

WASHINGTON (AP) _ Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers’ ability to sue drug makers, congressional investigators said Wednesday.

At issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called pre-emption.

Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.

“Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real time basis,” the report quoted Dr. John Jenkins, who oversees FDA’s new drug reviews, as saying. “We know that such an assumption is false.”

Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers.

In a case to be argued before the Supreme Court on Monday, a Vermont woman sued Wyeth after she lost her right arm below the elbow following a high-volume injection of the drug Phenergan. The injection accidentally punctured an artery, prompting gangrene to set in. Levine argued that the company had a duty to warn consumers that such injections could have devastating consequences. The state courts agreed, awarding her nearly $7 million.

Wyeth appealed, saying it was protected from such suits. It argued a state court cannot overrule the FDA’s judgment on label warnings.

FDA scientists had weighed the risks and benefits of Phenergan, used to treat nausea and allergies, when it approved the prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.

The FDA said in its 2006 rule and in a 2008 rule that state suits could encourage drug makers to propose unnecessary labeling. Such labeling could result in scientifically unsubstantiated warnings and less use of beneficial treatments.

Waxman’s staff obtained documents rejecting that warning. Jane Axelrad, an associate director for policy at the agency, wrote: “We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary,” she said. “To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information.”

FDA officials said the agency encourages robust debate on public policy, so some dissension can be expected.

“As in any organization, there is rarely unanimity of opinion,” said spokeswoman Rita Chappelle.

In the end, the agency determined that finalizing the rules were the appropriate action.

“It was appropriate because FDA is the public health agency charged by Congress with the responsibility to ensure that drugs and certain medical devices are safe and effective and that the labeling adequately informs users of the risks and benefits of the product,” Chappelle said. “In addition, the agency is uniquely qualified to make such important and complex judgments.”

Public Citizen, the consumer advocacy group, said the Bush administration had pushed pre-emption clauses in a wide array of regulations.

“This effort to prevent injured citizens from using the courts and holding negligent companies’ accountable must be stopped,” said Brian Wolfman, director of Public Citizen’s litigation group.

The report said the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were included.

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On the Net:

House Oversight and Government Reform Committee: http://oversight.house.gov

Supreme Court will be looking at drug maker liability

Gordon Johnson — Sat, 04 Oct 2008 13:00:00 +0000

Date: 10/4/2008 10:20 AM
By The Associated Press

The Supreme Court is back in session on Monday. One high-profile case they will be taking up involves drugmaker Wyeth.

—Drug maker liability: Vermont musician Diana Levine won a $6.8 million judgment against drugmaker Wyeth after having part of her right arm amputated in 2000 when an anti-nausea drug was injected improperly. Now Wyeth, backed by the Bush administration, wants the high court to rule that Food and Drug Administration regulation of prescription drugs — in this case, approval of warning labels for drugs — overrides state laws and makes it easier for companies to defend against consumers’ claims.