Charlottesville Personal Injury Lawyer - FDA

New FDA Initiative Seeks To Decrease Drug Dosage Errors

Greg Webb — Sun, 22 Nov 2009 08:52:53 GMT

In an attempt to curb the number of serious deaths and illnesses caused by misuse of medication, the Food and Drug Administration (FDA) is attempting to identify the most serious threats and find ways to avoid them through their Safe Use Initiative. The FDA called on doctors, other healthcare professionals and consumers in order to gain information about which drugs and circumstances may be particular problems; they will also be calling public hearings as well.

One of the main issues the FDA has identified is the overuse of acetaminophen, a pain reliever that can cause liver damage if taken in excess; because the drug is used in so many different medications, it is hard for the consumer to know how much he or she is taking. The FDA will also investigate information given to patients, such as labels, package inserts and directions that pharmacists use when distributing prescriptions. Such an investigation is long overdue since about 99.5% of pamphlets contain unregulated information that is missing critical information.

According to a 2007 study conducted by the Institute of Medicine, about 1.5 million preventable “drug accident events” occur annually in the United States; aside from the toll on health, this costs an estimated $4 billion each year as well. FDA officials acknowledged they do not have these hard figures since the term "preventable harm" encompasses a range of poorly tracked activities including accidental overdoses, distributing the wrong medication or the wrong dosage, abuse of medication and drug-quality defects; medication errors do not contain common side-effects.

This writer thinks this is a good initiative. One wonders how many incidents there are per year of unintended “misuse” of medications, through lack of education or information about the particular drug at issue. Many people overuse over-the-counter pain medications because they cannot afford prescription strength drugs.

Originally posted at InjuryBoard by Greg Webb

AstraZeneca’s Seroquel Subject of $520 Million Settlement

Greg Webb — Wed, 04 Nov 2009 17:58:05 GMT

AstraZeneca, a pharmaceutical company, has reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its best-selling psychiatric drug Seroquel. According to research firm IMS Health, Seroquel was the top selling anti-psychotic medication in 2004 with about $17 billion in sales. AstraZeneca joins a list of drug manufacturers forced to pay billions of dollars to settle inquiries filed by former company insiders.

AstraZeneca disclosed one of the investigations related to physicians who participated in clinical trials involving Seroquel and another related to off-label promotion of the drug. However, a company spokesman refused to give more specifics about the physicians or clinical trials under investigation. He also said the company was in final negotiations to settle the whistle-blower lawsuits and reach a corporate integrity agreement with the U.S. Justice Department.

As a result to the company’s aggressive marketing campaign, Seroquel has been used for children and elderly patients for indications not approved by the Food and Drug Administration (FDA); doctors are allowed to prescribe any approved medication for off-label uses. AstraZeneca has also said that as of October 9, it has been served with 14,444 civil lawsuits over Seroquel’s misleading marketing because many of the patients using the drug have developed diabetes and other health problems.

Originally posted at InjuryBoard by Greg Webb

FDA Slow In Banning Fraudulent Drug Researchers

Greg Webb — Sun, 01 Nov 2009 09:52:38 GMT

In a report scheduled for release on Thursday, Congressional investigators say the Food and Drug Administration (FDA) pays little attention to its duty to ban investigators that are convicted of fraud; it is so disorganized that it takes an average of four years to complete its actions. For example, Delfina Hernandez helped to implement one of the most audacious drug research frauds in American history. Hernandez was a study coordinator at the Southern California Research Institute, a drug testing operation in Whittier, California that federal agents raided in 1997. The institute conducted more than 170 drug studies for almost every major drug manufacturer in the world and regularly falsified patient records and data while doing so. Hernandez plead guilty to fraud, thus requiring the FDA to ban her from participating in further drug research. The agency had five years after her conviction to act, however, because regulators sent her a legal notice years late and to the wrong address, she can legally continue to conduct research. When the agency finally learned of its mistake, it was too late for the ban to take affect.

In a review of eighteen proceedings, investigators from the Government Accountability Office ("GAO") found it took anywhere between one to eleven years to complete its ban on fraudulent researchers. This means the researchers were able to conduct experiments for years following their supposed ban. The FDA has claimed it has corrected this problem with increased staffing and centralized coordination. House Representative Joe Barton, the senior Republican on the House Energy and Commerce Committee, criticized the FDA’s slowness in banning fraudulent investigators and has promised to introduce legislation to give the agency more power to ban researchers convicted of fraud from later participating in any kind of human research.

Congress needs to act quickly and decisively to correct this "loophole". This type of governmental oversight is unacceptable.

Originally posted at InjuryBoard by Greg Webb

Botulism Fear Shelves Plum Organics’ Baby Food

Greg Webb — Sun, 01 Nov 2009 09:36:02 GMT

Plum Organics, a California-based company, recently announced that it is recalling its apple and carrot flavored baby food for fear of botulism poisoning. The company stated its product does not meet FDA requirements. While there have been no illnesses reported, the possibility is not taken likely; botulism is a rare, serious paralytic illness. The baby food packages in question are 4.22 ounce pouches with a sell by date of May 21, 2010; their UPC code is 890180001221. They were sold at Babies “R” Us and Toys “R” Us stores nationwide.

Originally posted at InjuryBoard by Greg Webb

Procter And Gamble Scolded By FDA For Using Vitamin C In Products

Greg Webb — Sun, 25 Oct 2009 20:19:22 GMT

FDA (Food and Drug Administration) regulators are scolding Procter and Gamble for adding Vitamin C to its Vicks cold formulas, a combination not allowed by federal regulations; the FDA issued a warning to the consumer products company, stating medications such as Vicks Nyquil and Dayquil have not been approved to contain Vitamin C. Though Procter and Gamble claims Vitamin C can help to “blunt” the effects of a cold, an FDA expert panel found that Vitamin C is not explicitly effective for the prevention or treatment of the common cold. The FDA is tasked with verifying marketing claims about drugs.

Anecdotally, a lot of people swear by Vitamin C for cold prevention. Studies do not seem to support that, however. I would be interested to know how many people believe that Vitamin C has prevented them from getting a cold, or prevented the cold from getting worse.

Originally posted at InjuryBoard by Greg Webb

Controversial Medical Device - Menaflex - Approved By FDA

Greg Webb — Wed, 07 Oct 2009 17:11:15 GMT

In a bid to get a controversial knee-surgery device known as Menaflex approved by the Food and Drug Administration (FDA), ReGen Biologics relied too heavily on two consultants with strong ties to Congress and the FDA. One consultant previously worked as the FDA’s associate chief counsel for medical devices and had regular contact with the agency about the device; the device was approved last December despite staff objections. Another top ReGen consultant is the former chief of staff to Senator Robert Menendez, who was among four lawmakers that signed a letter urging the FDA to review the case. Campaign finance records also show that one of these consultants contributed about $40,000 to Menendez and the other three New Jersey politicians that signed the letter.

The two consultants were part of an aggressive campaign by ReGen to obtain approval for Menaflex, which is a surgical mesh used to aid in repairing torn knee tissue. FDA staff scientists rejected Menaflex three times, citing concerns that patients may experience adverse effects and that the manufacturer had not provided enough evidence that the device was more effective than routine surgery. However, in late 2008, ReGen appealed to Andrew von Eschenbach, the FDA Commissioner, who ordered an expedited review by a panel of independent advisers, allowed ReGen input regarding the composition of the panel and refused to permit FDA staff scientists who had been reviewing the Menaflex applications to address the panel. An internal probe found ReGen had remarkable access to von Eschenbach and approval came after he met with the New Jersey legislators who asked von Eschenbach to handle the matter personally. According to the Center for Responsive Politics, ReGen has spent $500,000 lobbying in Washington since 2007. Three of the company’s executives also gave substantial sums of money to the campaigns of the lawmakers that signed the letter to the FDA, though the congressmen’s aides claim the contributions played no role in their decision to approach the FDA.

The exposure from this ReGen case and how the FDA is now considering approving the Menaflex has alarmed not only public interest groups seeking FDA reforms, but also the $200 billion medical device industry, which is also seeking changes to health-care reform legislation making its way through Congress.

Originally posted at InjuryBoard by Greg Webb

FDA Pulls the Plug on Flavored Cigarettes

Greg Webb — Sun, 04 Oct 2009 21:46:30 GMT

The FDA has banned flavored cigarettes from the market as its first act since being given the authority to monitor and regulate the marketing and manufacturing of tobacco products. It is widely viewed that flavored cigarettes serve as a draw to usher teenagers into smoking, eventually leading to a regular habit with studies showing that almost one in every three teenagers who start smoking become daily smokers.

The New York times reported in its article “Flavors Banned from Cigarettes to Deter Youths” that “In 2004, 17-year-old smokers were more than three times as likely as those over the age of 25 to smoke flavored cigarettes, and they viewed flavored cigarettes as safer.” The ban will hopefully have a butterfly effect in the number of smokers it decreases, as well as the potential millions of dollars in health care costs it may eliminate down the line.

One of the problems with the new legislation is that the law does not clearly denote what constitutes a cigarette.

The most common distinction between a cigar and a cigarette is in the way each is wrapped, with cigars being rolled in tobacco leaves and cigarettes being cased in paper. Officials have been “deliberately vague” in letting the public know whether the ban would apply to flavored small cigars and cigarillos.

In a letter to tobacco manufacturers the agency noted that the ban applied to all “cigarette-like” products, regardless of how they are packaged and/or marketed.

Part of the confusion is due to the strict deadline that the agency had to meet. It only had 90 days to put the ban on flavored cigarettes into effect.

Catherine Lorraine, a lawyer in the agency’s tobacco center, said, “We will be looking at products on an individual basis to determine if it meets that aspect of the legislation.”

For some customers, the ban has been an education on switching from flavored cigarettes to flavored small cigars. Brian M. Mulholland, general manager of Georgetown Tobacco in Washington, said customers are “making the transition.”

The ban does not include menthol cigarettes, as the new law makes specific note that menthol cigarettes are to be researched and dealt with independently. USA Today’s article “FDA: Sweet-flavored cigarettes cannot be sold” cites a study published earlier this year that found that menthol cigarettes “make smoke less harsh, so smokers can take in more nicotine and carbon monoxide per cigarette.” Jonathan Foulds, director of the Tobacco Dependence Program at the Unviersity of Medicine & Dentistry of New Jersey-School of Public Health, is not surprised that the agency went after flavored cigarettes before menthol cigarettes.

Menthol cigarettes are “far bigger sellers” and would have likely lead to a “pretty major revolt from industry.”

Originally posted at InjuryBoard by Greg Webb

Supplements - More Dangerous Than They Appear (Or Advertised)?

Greg Webb — Fri, 25 Sep 2009 01:00:00 GMT

In its September 7^th article “What’s Really in Supplements?” The Wall Street Journal (WSJ)discusses the harmful side effects of a growing trend in the American dietary and strength conditioning communities: the taking of over-the-counter supplements.

Many supplements purport to aid in the building of muscle mass or in weight loss, claiming to do what prescription or illegal drugs do via an herbal means. However, the truth is that a great deal of these supplements contain at least trace amounts of the very drugs they claim to emulate.

Recent reports from the Food and Drug Administration (FDA) address the discovery of illegal performance-enhancing drugs in “allegedly natural supplements.” The WSJ article states that “[n]early two-thirds of American adults take dietary supplements, a broad category that includes vitamins, minerals and herbal products.” Supplement manufacturers are able to get their products quickly to market because they don’t require the extensive testing that new drugs do, and thus don’t require approval by the FDA. Furthermore, the WSJ says that “supplements that are made from products that were on the U.S. market before 1994 – as most commonplace ones are – can be sold without being reviewed by the FDA beforehand. Companies that include newer substances are supposed to inform the agency before they go on the market, but they don’t have to wait for approval.”

The recent attention stirred by the reports will be discussed during a hearing this month by a Senate Judiciary subcommittee. The focus of the hearing will be on dietary-supplement safety.

While officials at the Council for Responsible Nutrition are arguing that “no new laws are needed, citing new FDA manufacturing standards for supplements…as well as a requirement for supplement makers to tell the FDA when they get reports of serious side effects, which took effect at the end of 2007,” consumer advocates continue to call for closer monitoring.

A 2007 survey conducted by the British lab HFL Sport Science regarding supplements “found the undisclosed presence of steroids in at least trace amounts in 25% of the 52 samples analyzed,” and a 2008 article published in the journal Gastroenterology claimed that “9% of the 300 cases then recorded” could potentially be linked to supplement-taking. Since December 2008, “the FDA has issued warnings about more than 70 weight-loss supplements that included potentially dangerous ingredients.” The side effects of such ingredients could include seizure, heart attack and stroke. Liver and kidney failure have also been common in cases where a supplement taken regularly contained anabolic steroids. “Ed Wyszumiala, general manager of dietary supplement programs for NSF International, a nonprofit organization in Ann Arbor, MI that certifies supplements’ safety, says the drugs and steroids likely get into the products through a combination of deliberate spiking and inadvertent contamination.”

Vice President Andrew Shao of the Council for Responsible Nutrition “says safety problems are a ‘rare occurrence.’” He considers the HFL survey a “‘marketing tactic’” and says that consumers need to know what they’re taking as well. This is true. Consumers who take dietary supplements should be aware their ingredients and what those ingredients do. Research has been conducted on numerous herbs, most of which can be found online. In addition, Travis Tygart, chief executive of the U.S. Anti-Doping Agency, says that people who are interested in take supplements should speak with a physician. This would also help prevent dangerous interactions between prescription drugs and the supplements.

Preventative measures could include researching evidence, side effects and interactions at the National Library of Medicine (www.medlineplus.gov) under “Drugs and Supplements,” searching for specific supplements at www.fda.gov, as well as reading closely into what a supplement’s packaging discloses in subtext. “Certain suffixes in chemical names are common for steroids or tweaked versions of them. Among them are –one, -ene, -iol and –bol, though these can also appear in the names of legitimate ingredients. Some products also use versions of steroid names in their brands, like ‘tren’ to connote trenbolone.”

People using supplements should be aware of warning symptoms that could be indicative of an escalating problem. These include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellow corneas and skin, and discolored urine, as cited by the FDA as warning signs of potential steroid use.

The Wall Street Journal article contains a complete list of resources for researching supplements.

Originally posted at InjuryBoard by Greg Webb

Bayer Warned By FDA Regarding Birth Control Products Quality

Greg Webb — Thu, 24 Sep 2009 22:00:35 GMT

Food and Drug Administration (FDA) regulators have written a letter warning drugmaker Bayer about quality control issues in the company’s plant in Berghamen, Germany. This plant is responsible for making drospirenone, the key ingredient for popular birth control drugs like Yaz and Yasmin; these products were Bayer’s top selling pharmaceuticals last year, with global sales of $1.8 billion. Instead of reporting individual tests results, FDA officials said the company measured the quality of its drug ingredients based on an average of several samples; Bayer shipped eight drug batches to the U.S. to be tested for quality using the sample average method, however the FDA does not allow this.

In April, Bayer responded to the FDA’s allegations by stating the quality in all drug batches shipped to the U.S. between 2007 and 2009 were not affected. In response, the FDA wrote another letter disagreeing with Bayer’s “rationale and conclusion.” While the FDA has not advised patients to stop using the products, they have asked Bayer to supply an entire list of all shipments to the U.S. that may have used the averaging method and provide a plan that would prevent the problem from recurring. The agency also said it was considering delaying imports from the German factory until Bayer addresses the warning letter.

New FDA Commissioner Margaret Hamburg has announced many changes designed to speed the pace of warning letters. This includes a streamlined review process for sending letters and shorter deadlines for companies to respond.

Originally posted at InjuryBoard by Greg Webb

Federal Concerns About Electronic Cigarettes Are Growing

Greg Webb — Thu, 13 Aug 2009 12:17:06 GMT

Because so little is known regarding what is in electronic cigarettes, regulators are growing more and more concerned due to the increase in popularity of the product over the past several years. Preliminary tests carried out by the Food and Drug Administration (FDA) show e-cigarettes, which are battery operated tubes that deliver a nicotine vapor instead of burned tobacco smoke, contain some of the dangerous carcinogens that traditional cigarettes do, but at lower levels. The samples also revealed quality-control issues with some of the products, which are marketed the exact same, having wildly variable amounts of nicotine and one of the products even having poison (diethylene glycol) in it; this indicates that regulators do not know enough about how the product is being produced. Due to the study’s findings, the FDA Commissioner has warned consumers to beware.

Since e-cigarettes, or "e-cigs", are being subject to FDA approval as a drug or medical device, they are illegal until they are cleared. Smoking Everywhere, one of the two major importers of e-cigarettes, has since sued the FDA, claiming it should not be regulated like a drug but as a tobacco product. While the company engages in this legal battle, however, its sales representatives at one point claimed the product had been approved and deemed safe by the FDA. An attorney for the company claims this misinformation has since been corrected.

Michael Siegel, a Boston University School of Public Health Professor, says the FDA’s newest consumer warning is misleading because the agency found very low levels of carcinogens in e-cigarettes. Siegel claims these levels were comparable to what is present in nicotine-replacement products, which are currently on the market. He also states the levels of carcinogens in the e-cigarettes are about 1,400 times lower than in Marlboros. The FDA deputy commissioner, however, says it is premature to claim e-cigarettes are safe until regulators know what is in them. If the product is meant to help some Americans stop smoking, it is the manufacturers obligation to present that data to the FDA.

Many anti-smoking advocates are putting pressure on the FDA to officially ban e-cigarettes from the U.S. They claim these and similar products should be taken off the market because the lack of testing to determine the hazardous ingredients in the product would lead to smokers becoming guinea pigs. The public health community is also split over the issue regarding whether to advocate smokers switch to a less harmful product even if they are not completely safe. Though the government has blocked the product from the border, it has not shut down domestic retailers. This means consumers can find the $40 to $100 e-cigarette starter kit in mall kiosks, travel centers and online. So far, the e-cigarettes have also been banned in Canada, Australia, Mexico and Israel.

Originally posted at InjuryBoard by Greg Webb