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FDA News
FOR IMMEDIATE RELEASE
March 2, 2009

FDA Takes Action Against KV Pharmaceutical Company
Company Making, Marketing and Distributing Adulterated and Unapproved Drugs
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality, and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until the company’s procedures and products are brought into compliance with the law.

KV Pharmaceutical manufactures, processes, packages, labels, holds, and distributes drugs from various locations in St. Louis, Mo., and the surrounding area. FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of those inspections, which led to this action, KV recalled all products manufactured and distributed from its facilities.

“The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of their facilities and certify that they are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the decree. The Consent Decree also requires the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009. Those drugs are currently in their possession.

If the defendants fail to comply with any provision of the Consent Decree, the Act, or FDA regulations, FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions.

“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.

For more information:

FDA/CDER Web page on Compliance with Current Good Manufacturing Practices
http://www.fda.gov/cder/dmpq/

FDA’s ongoing efforts against marketed unapproved drugs
http://www.fda.gov/cder/drug/unapproved_drugs/

Federal Agents Seize more than $24M in Unapproved New Drugs
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01868.html

Ethex Corporation Initiates Nationwide Recall
http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html

KV Voluntarily Suspends Shipments of all its Approved Tablet Drugs
http://www.fda.gov/oc/po/firmrecalls/kv12_08.html

Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm

EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers

WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.

“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”

Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.

“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”

Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.

The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.

As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.

Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.

The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.

This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.

Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.

Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.

It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.

Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.

The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.

FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.

“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.

“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”

___

Baker reported from Raleigh, N.C.

___

On the Net:

FDA Science Board report — http://tinyurl.com/yvnk28

Copyright 2009 The Associated Press.

By BRETT J. BLACKLEDGE
Associated Press Writer

WASHINGTON (AP) — A peanut processing plant in Texas run by the same company blamed for a national salmonella outbreak operated for years uninspected and unlicensed by government health officials, The Associated Press has learned.

The Peanut Corp. of America plant in Plainview never was inspected until after the company fell under investigation by the U.S. Food and Drug Administration, according to Texas health records obtained by AP.

Once inspectors learned about the Texas plant, they found no sign of salmonella there. But new details about that plant — including how it could have operated unlicensed for nearly four years — raise questions about the adequacy of government efforts to keep the nation’s food supply safe. Texas is among states where the FDA relies on state inspectors to oversee food safety.

The salmonella outbreak was traced to the company’s sister plant in Blakely, Ga., where inspectors found roaches, mold, a leaking roof and internal records of more than a dozen positive tests for salmonella.

The outbreak so far has resulted in more than 500 reported illnesses, led to an expansive recall and caused as many as eight deaths. The government is working on a criminal investigation in the case.

In Texas, inspector Patrick Moore of the Department of State Health Services was sent to Plainview, in the sparsely populated Texas Panhandle, after salmonella was traced to the company’s plant in Georgia. Moore said the Texas plant wasn’t licensed with health officials and had never been inspected since it opened in March 2005. Texas requires food manufacturers to be licensed every two years and routinely inspected.

“I was not aware this plant was in operation and did not know (what) type of products processed,” Moore wrote in an inspection report obtained by AP.

The plant is registered with the Texas Comptroller of Public Accounts to do business as Plainview Peanut Co. LLC, according to state records. But the company “was unable to present evidence at the time of the inspection of a current food manufacturers license,” Moore wrote in his report.

The plant was properly registered with the FDA as a food processing plant, said David Glasgow, director of the agency’s investigations branch in Dallas. FDA inspectors went through the plant two weeks ago after the state inspection and did not find salmonella or other problems, Glasgow said.

Texas ordered its inspection Jan. 12 during the FDA’s investigation of the Georgia plant, after it received reports that Peanut Corp. was operating the plant in Plainview, health services spokesman Doug McBride said. Texas requires food companies to obtain two-year licenses but doesn’t have enough money or inspectors to catch companies that don’t.

“We can’t drive up and down the street to know what people are doing behind closed doors,” McBride said.

Moore reported some unsanitary conditions, such as unclean sections of a peanut roasting line. But several internal company laboratory tests dating back to November found no salmonella or other contaminants, according to documents included in Moore’s report.

Plant manager Jesus Garrocho told Moore that he sent Texas health department forms to the company’s Virginia headquarters more than a year ago and did not know why the licensing forms were not completed.

Moore said the plant manager promised during the January inspection to register the plant with state health officials: “He will make sure this gets in and paid,” Moore wrote.

McBride said the company still hasn’t done so.

“Our first preference is not to go out and shut somebody down and wipe out jobs and income,” he said. “Our philosophy in any of our regulatory programs is to try to get a company in compliance.”

The plant is the subject of a complaint filed since the state’s inspection Jan. 12, and is scheduled for a new inspection in coming weeks, McBride said. He would not provide details about the complaint.

Garrocho referred questions Monday to company lawyers. Amy Rotenberg, a Minneapolis lawyer representing Peanut Corp., declined to comment.

The Texas plant blanches, dry roasts, oil-roasts and chops peanuts, then ships them to food companies across the country. The Georgia plant also processes peanuts, and produces peanut paste and peanut butter.

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the scientists wrote.

FDA spokeswoman Judy Leon said in response: “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency’s reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The blockbuster asthma drug Advair does not appear to have an increased risk of serious complications seen with similar new medicines, federal health officials said Friday.

But a less widely used medication, Serevent, had a significantly higher rate of serious complications, and even deaths, the Food and Drug Administration said. Both medicines are made by the same company, GlaxoSmithKline.

The FDA is concerned about asthma drugs known as LABAs, long-acting medications that relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.

But LABAs, for reasons that are still being debated, can increase risks of death and complications in some patients. The risk is lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways.

Advair combines both kinds of medicine in one inhaler. But Serevent is a LABA-only product, although medical treatment guidelines call for patients taking the medication to also use a steroid.

The FDA analyzed reams of clinical data on four drugs: Advair, Foradil, Serevent and Symbicort. All four already carry strong warnings, but the findings could lead to more specific instructions for patients and greater restrictions on some of the medications. The agency has called a special meeting of outside advisers next week to discuss the data and make recommendations.

GlaxoSmithKline said the analysis underscored its confidence in Advair, its best-selling medication, with U.S. sales of $2.9 billion in the first nine months of this year. But a spokeswoman declined to comment on whether the data could lead to a withdrawal of Serevent, which had U.S. sales of $97 million in the same period. About 4 million U.S. patients now use the Glaxo medications.

Asthma is a chronic respiratory illness that leaves patients short of breath, wheezing, and can sometimes send them to the emergency room because of difficulty breathing. Some 22 million people in the United States suffer from asthma, and children account for nearly one out of every three patients. Nearly 3,600 people still die from asthma in this country each year, although symptoms can be controlled with medication to prevent the most serious complications.

Copyright 2008 The Associated Press.

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects.

The regulatory agency is considering requiring TV promotions to carry a toll-free number where patients can report serious problems with their medication. However, some critics argue the toll-free number could distract viewers from other important safety information about the drugs.

Print advertisements already include contact information for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that information should also be mandatory for TV ads.

But the agency requested more time to complete its work and is expected to soon begin a formal study of the question — well over a year after the drug safety legislation was signed into law.

On Tuesday the agency laid out plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical information.

Pharmaceutical “ads are already quite dense when compared with ads for other products,” the agency states in documents posted online. “The risk information should not be compromised by the addition of the toll-free statement.”

Drug promotions are already required to list a drug’s benefits and risks.

For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the information they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension.

Regulators did not say when they would launch the study, but the FDA said it would accept comments on the proposal for the next two months.

The Pharmaceutical Research and Manufacturers of America has not yet taken a stance on the issue. However, the group — which represents Merck & Co. Inc., Pfizer Inc., Wyeth and other drugmakers — supported adding the language about side effects to print ads.

TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on commercials last year.

But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.

By the time the FDA completes its study of the toll-free number, policymakers in the now Democrat-dominated Washington may have already moved ahead with even stricter regulations.

Rep. Rosa DeLauro, D-Conn., introduced a bill this spring that would ban consumer-directed advertisements during the three years after a new drug’s launch. The proposal is aimed at limiting the use of new drugs until they have been demonstrated safe.

The legislation would also require drugmakers to mount public awareness campaigns about the risks of certain types of drugs. DeLauro is expected to reintroduce the measure next year.

“The FDA has important drug oversight responsibilities, and the push to promote new drugs and devices should not get in the way,” DeLauro said, upon releasing the bill.

Copyright 2008 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ Hundreds of thousands of baby boomer women who think they’ve found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday.

A panel of independent advisers urged the Food and Drug Administration to revise the labeling to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars.

“It is almost a no-brainer,” said Dr. Michael Bigby, a Harvard Medical School dermatologist. “The current label is not adequate.” The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But Tuesday’s FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The hearing was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help the government track safety, improve training and provide clearer information to consumers.

Women, and even some men, are drawn to skin fillers by the promise of youthful good looks at far less cost and trouble than a face lift. A touchup two or three times a year can boost deflated middle-age egos. Unfortunately, for some patients, the result can be blotchy skin, bumps on the face and worse.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they’re injected into the face. They include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There are also questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

“The trouble is that once this material is in the hands of physicians, there’s really not much control over how it’s used and where it’s placed,” said Dr. Scott Spear, a Washington plastic surgeon. “That creates the potential for a certain amount of mischief.

“But the good news is that, by and large, these are very safe materials,” Spear added. “They have a very healthy risk profile.”

FDA scientists will present the advisory panel with data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

Most reactions involved minor swelling and redness, complications that could be expected. But the FDA said it also received reports of “serious and unexpected” problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

A small number of patients — 19 — went to the emergency room with life-threatening allergic reactions, such as difficulty breathing. Twelve developed infections that required hospitalization.

“The FDA has been rushing these products to market as if they were lifesaving medical products,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. “They should be requiring better studies since these products have only cosmetic benefits but potentially lethal risks.”

Some problems reported to the FDA may be due to unapproved or “off-label” use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.

Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.

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On the Net:

Food and Drug Administration: http://tinyurl.com/5jtuxv

Copyright 2008 The Associated Press.