FDA Regulations

Last week, a Senate committee gathered to understand how medical devices are approved by the U.S. Food and Drug Administration (FDA). Senators heard medical device makers accuse the FDA of a slow approval process for devices which they claim costs money and jobs. Manufacturers are in favor of pushing for a streamlined process to get devices to the market faster, although about 90 percent of new medical devices are already fast-tracked through the FDA’s little-known 510(k) process that is basically an exchange of paperwork to assure regulators that the device is similar enough to one that was grandfathered in the 1970s.

Now, Consumers Union, the advocacy arm of Consumer Reports, has added its voice to the few who were present to remind the FDA that it cannot serve two masters – the medical device manufacturers and the public who it is supposed to protect. Consumers Union is in favor of strengthening the federal regulation of medical devices.

“You have been hearing that the medical device industry faces onerous regulation by FDA. But in many respects, the device industry is far less regulated than the drug industry. For example, the standards for the fuller premarket approval of devices that require clinical trials are weaker than are used for drug approval. Drugs must show substantial evidence of safety and effectiveness where devices must merely show reasonable assurance of safety and efficacy,” said Lisa McGiffert, the Director of the Safe Patient Project.

Consumers Union wants medical devices such as surgical mesh to undergo premarket approval for safety by the FDA as well as implementing a post-market surveillance of the devices so patients can be followed and alerted when there is a problem with a device.

A product liability action is filed when a device is defective in its design or manufacture and/or when the manufacturer fails to adequately warn the public about the defective nature and complications associated with a medical device. Without a warning, a patient cannot make an informed decision on whether or not he or she wants the product.

So many women who have synthetic surgical mesh implanted had no idea whatsoever what was being used to treat their pelvic organ prolapsed or incontinence, nor were they warned about the injuries associated with this defective device. If you have been injured by a synthetic surgical mesh, the experienced Florida transvaginal mesh attorneys at Farah & Farah are ready to listen to you and help. Call (800) 533-3555.

Source: http://news.consumerreports.org/health/2011/11/lax-oversight-of-medical-devices-puts-patients-at-risk-consumers-union-says.html; http://www.consumersunion.org/pub/core_health_care/018231.html

The U.S. Food and Drug Administration (FDA) is stuck between a rock and a hard place.

On Tuesday, November 15, the Senate Committee on Health Education Labor and Pensions held a hearing on how the FDA’s approval of medical devices is working. There are two ways a medical device, such as surgical mesh or a hip implant, makes it to the market. The device either is submitted for approval through a premarket application (PMA), reserved for high risk devices, which requires a review of the clinical data to assure safety, or the fast-tracked 510(k) way that allows manufacturers to claim their device is similar to one already on the market and therefore does not need a redundant review by regulators.

In the real world, the FDA looks at very few devices through a PMA application. The majority of devices are approved through 510(k). This is why we have some defective medical devices allowed onto the marketplace that can actually injure or kill users, such as synthetic surgical mesh used in women to reinforce the pelvic region when organs prolapse or to treat incontinence.

Despite the thousands of injuries and deaths that have resulted, the majority of surgical mesh remains on the market. It never underwent PMA to assure safety for consumers.

In the opening statement by Sen. Mike Enzi, he voices concern about the disadvantages medical device manufacturers face with no mention of injured patients. He said manufacturers are concerned because the time to review a PMA has skyrocketed, roughly doubled between 2000 and 2008, and that means that manufacturers may take innovations overseas to seek approval. Enzi says the FDA has made it harder, not easier, to get devices to the market, arguing that the percentage of 510(k)s is found not to be “substantially equivalent” or withdrawns doubled between 2006 and 2011.

As a consumer, don’t you want the FDA to be regulating and rejecting some devices that are not substantially equivalent to another device?

U.S. Sen. Tom Harkin (D-IA) sounded more like the voice of the consumer when he said there is no virtue to getting these devices to market “if they don’t work or worse cause injury or death.”

People would be shocked if they understood the regulatory process, said Harkin. The 510(k) process requires a predicate device be named, but in some cases, such as the surgical mesh predicate, it was removed from the market because of safety concerns.

Boston Scientific’s ProteGen Sling was recalled on January 22, 1999. The reason stated in the FDA’s March 17, 1999 Enforcement Report was “Use of the ProteGen in female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

You would think that alarm would cause all devices that used it as a predicate to be reviewed. You’d be wrong. According to Sen. Harkin, “Certainly if a device turns out to be dangerous, if its withdrawn or recalled, its absurd to continue to use that device as a predicate for later products.” If you or a loved one has suffered any injuries or health problems due to a defective medical device, please call the Florida product liability lawyers of Farah & Farah at (800) 533-3555 for a no-cost consultation.

Source: http://help.senate.gov/newsroom/press/release/?id=3eae5a3a-bdf8-4744-ad1f-e1383725136d&groups=Ranking

As if it were proud, the U.S. Food and Drug Administration (FDA) issued a press release Thursday, November 3, announcing that 35 new drug medications were approved in this federal fiscal year. This comes as the agency takes criticism from the biotech and medical device industries that it is too slow in approving new drugs and devices for the market.

The agency said this is the second highest number of drug approvals and that the majority of the drugs, 24 total, were approved in the U.S. before other countries, where gaining approval is usually easier. Included in the approvals was a new drug for Hodgkin’s lymphoma and one for late stage melanoma that may prolong survival.

FDA Commissioner Margaret Hamburg called it a “very strong performance.”

The biotech and medical device industries want to weaken the approval process so devices and drugs can make it to the marketplace faster and are pushing back on a proposal to ask for more information before approval.

All of this is very upsetting news to consumers and patients who have been injured by drugs and devices introduced into the market with little scrutiny and which were later found to be dangerous.

Case in point: synthetic medical mesh, which is coming under fire as hundreds of lawsuits are filed from patients suffering devastating and permanent injuries from the plastic material that erodes and hardens in the body of men who used the mesh for hernias, and women who were treated for pelvic organ prolapsed and incontinence with mesh.

Mesh was approved for the market under the 510(k) procedure, meaning it had to apply to be marketed with no requirements for safety. Metal-on-metal hip implants are another medical device that got the pass from the FDA before being put on the market. With a high failure rate, the implants must be removed and replaced, adding an additional risk of injury to the patient.

The Florida product liability lawyers of Farah & Farah feel that to ensure the public’s safety, the FDA needs to review devices and drugs more closely, not less. Congress is currently considering a medical device fee that is negotiated every five years, according to a story in the New York Times, and helps finance the agency. Without fees, the FDA will have to lay off many staff members who are needed to review the safety and efficacy of drugs and devices.

Source: http://www.fairwarning.org/2011/11/under-pressure-fda-points-to-increased-drug-approvals/; http://www.nytimes.com/2011/11/04/health/policy/drug-approvals-rise-for-fda.html?scp=2&sq=hamburg&st=cse

Americans eating fish imported into the U.S. may be getting more than they bargained for.

FairWarning.org reports that chemicals banned in this country including carcinogens, are routinely showing up in imported fish, a cause for concern since 80 percent of fish eaten in this country is caught outside of the U.S. Three fish importers in Mobile, Alabama have pled guilty to felony charges of mislabeling fish brought into Mobile and Seattle that contained the carcinogen, malachite green, and for an antibiotic prohibited from being sold in fish consumed in the U.S.

The General Accounting Office (GAO), in an audit released in April, blames the Food and Drug Administration (FDA) for screening less than one percent of fish coming into the U.S. Unless a state has a fishing industry, it usually does not test.

Florida does test its fish and in 2007 found 19 percent of catfish tested were positives for the antibiotic, flouroquinolones. Along with Alabama, which also tests, Florida officials have been detecting dangerous drugs in imported fish as well as banned chemicals used to fight parasites and diseases common among farmed fish.

The Food Safety Modernization Act, signed into law in January, promises to give the FDA new tools to hold food importers to the same standard as domestic food marketers.

It’s estimated about 48 million Americans are sickened and 3,000 die from food borne diseases each year, according to the Centers for Disease Control and Prevention (CDC). If you or a loved one are sickened by unsafe foods that a distributor knew or should have known was dangerous, you may have the basis for a product liability lawsuit in Florida to stop the wrongdoer and recover your medical expenses, lost wages, and other costs.

Sources: http://www.fairwarning.org/2011/07/imported-fish-with-banned-chemicals-reaching-u-s-consumers/ and http://www.fda.gov/Food/FoodSafety/FSMA/ucm237934.htm

Food coloring is used to make fruit cereals more colorful, candies brighter, and processed food look more like real food. Food scientists and public health advocates say consumption of food coloring has more than doubled since 1990 and for 30 years scientists have suspected a link between hyperactivity and food dyes. An advisory panel to the Food and Drug Administration (FDA) replied recently to a 2008 petition filed by the Center for Science in the Public Interest to ban Yellow 5, Red 40, and six other food colorings, reports The San Francisco Chronicle.

One mother testified to the panel that eliminating food dyes from the diet of her 7-year-old resulted in a dramatic behavior changes and better grades. The FDA agrees that certain children are particularly susceptible to the effects of food dyes. The advisory committee had the option of recommending more study on the link to attention deficit disorder, better labels on foods that contain food colorings, or do nothing at all. In a concession to the food industry, on Thursday, March 31, the panel voted that the issue needs more study and that labels on foods with artificial dyes will not be necessary at this time, according to The Boston Herald.

Interestingly, European consumers have said no to food dyes and manufacturers have responded by using fewer dyes in food sold in Europe.

Consumers injured by dangerous or defective foods may have some remedy through the courts if they can prove the connection between an injury and the food consumed. For the most vulnerable, children and those immune compromised or the elderly, a food contamination sickness can result in severe injury or death. E. coli and salmonella contamination cases have resulted in successful litigation outcomes for the injured consumer and ultimately litigation discourages food manufacturers from sub-standard food safety practices.

The Florida product liability attorneys of Farah & Farah will investigate the source of your injury and may be able to hold the responsible party accountable for your medical bills, the cost of rehabilitation, lost wages, pain and suffering, and more.

President Obama signed the much heralded FDA Food Safety Modernization Act into law on Tuesday, January 4. The Act is supported by public health, industry and food safety groups, according to a report in Food Safety News.

The Food and Drug Administration (FDA) will now have authority to regulate about 80 percent of the U.S. food supply and the Act gives the agency more muscle to call for mandatory food recalls for unsafe or adulterated foods instead of requesting the recall as has been customary. Foreign food manufacturing facilities that import into the U.S. will have to meet U.S. standards and growers and food plants will have to implement a food safety plan and provide the agency with test results. Grocery stores will also have to post notices about food recalls so consumers have that information while they are shopping.

The provisions are to be implemented over several years with the exception of the mandatory food recall powers by the FDA, which will go into effect immediately. An immediate recall power means the nation does not have to wait while the FDA negotiates with a company over whether its products are contaminated with E. coli, salmonella, or listeria.

At the same time, the GOP announced plans to cut FDA funding for the new safety laws, estimated to cost $1.4 billion.

The Centers for Disease Control and Prevention estimate there are 48 million cases of foodborne illnesses, 128,000 hospitalizations because of foodborne illnesses, and 3,000 foodborne illness-related deaths every year in the United States.

The Florida product liability lawyers at Farah & Farah have many years of experience handling a wide variety of product liability cases in Florida, and it makes us well-equipped to handle the most complex product liability and adulterated food cases. Call us so we can begin an investigation into your case.

In China, when an executive of a major company is found to have a manufacturing problem that results in consumer deaths, the executive may turn to suicide. That’s not the case here in the U.S. where executives regularly flaunt health and safety regulations to the detriment of the public. Regulators at the U.S. Food and Drug Administration have generally been the passive tail being wagged by the corporate dog, but there seems to be a groundswell within the agency to change the way it does business.

High profile recalls are prompting the change, along with new leadership that has vowed it will not be business as usual and criminal charges may be in order.

CNN reports FDA Commissioner Margaret Hamburg wrote to Sen. Chuck Grassley, R-Iowa, in March to say that the agency intends to consider “the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable.”

For example, the recent series of pharmaceutical recalls of Tylenol and children’s cold and allergy over-the-counter medications, made by McNeil, a subsidiary of Johnson & Johnson, may be the first to fall under the ax.

The FDA would pursue criminal convictions for violations of the federal Food, Drug and Cosmetic Act against executives who knew or should have known about manufacturing problems that threaten public safety.

In the case of J & J, the children’s Tylenol plant in Pennsylvania was found to have multiple violations including bacterial contamination, an open roof, and inconsistent formulations. The plant is still closed. Many children reportedly were sickened.

The problem has been the “get government off our backs” attitude of industry and a compliant federal leadership. With corporations setting their own rules, FDA enforcement and inspections dropped. CNN reports there were 600 criminal prosecutions against companies in 1939. By 1989 that number had dropped to 16.

Things seem to be changing. In 2009, there were more than 1,742 drug recalls and 684 food recalls in 2010. Food recalls also come under the umbrella of the FDA.

The message is clear to industry – clean up your act or you could go to jail. A felony conviction could result in a $10,000 fine and up to three years in prison.

Since the FDA is funded by our tax dollars and it in charge of protecting the public, shouldn’t we have insisted on this all along?

What could be worse behind the wheel than a drunk driver? How about a drunk driver also on caffeine? The drink in question is called Four Loko and if you haven’t heard of it, likely your college student or teen acquaintances have. It’s one of a handful of drinks aimed at mixing two types of highs at once.

Four Loko has an alcohol content of 12 percent. Consider that a beer has half or one-third of that. The 23.5 ounce colorful can also has a load of sugar. Similar drinks go by the name of Liquid Charge, Rockstar 21, and Torque.

In Florida, the drink made headlines recently when a 20-year-old driver was found to have mixed Four Loko with liquor and marijuana before driving through a red light in St. Petersburg, killing a family of four.

Popular Among the Young
The Food and Drug Administration (FDA) believes about 26 percent of college students have consumed these high-alcohol, high-caffeine drinks and it is considering a ban.

Last November, the FDA sent letters to 27 manufacturers asking for some explanation as to why the drinks should not be banned. While caffeine alone is considered safe and alcohol is lawful under certain circumstances, mixing alcohol and caffeine together in a product for sale is not legal unless it receives FDA approval.

So far, 19 of the drink makers have responded to the FDA. They may have an argument in that caffeine is added to some soft drinks in low concentrations of less than 200 parts per million.

Four Loko is made by Drink Four Brewing Company of Milwaukee and distributed by Phusion Projects. The company does not disclose the caffeine count, but similar energy drinks such as Monster contain 160 mg of caffeine, Amp contains 143 mg, Xenergy has 200 mg.

An eight ounce cup of coffee contains about 100 mg of caffeine.

Congress is involved as well and wants to know how the caffeinated alcohol drinks can be marketed in a way similar to energy drinks, with colorful large cans and on social media sites to customers who are under the drinking age of 21.

A company spokesman tells TBO.com that they work hard to make sure the product is sold to adults over the age of 21.

Fearing product liability lawsuits, Anheuser-Busch and MillerCoors stopped producing caffeinated alcohol drinks after attorney generals in several states accused them of marketing to underage drinkers. Smaller companies have since filled the niche.

Miracle Mineral Solution (MMS) is a liquid nutritional supplement that promises to treat diseases from the common cold to cancer. MMS is sold over the internet and online auctions by various independent distributors. Also known as “Miracle Mineral Supplement,” the Food and Drug Administration (FDA) has issued a warning to consumers not to take the product because it contains industrial bleach.

The bleach has been known to cause serious harm to consumers. The FDA has received several reports of injuries including life-threatening low blood pressure, dehydration, vomiting and severe nausea.

The MMS label tells consumers to mix the liquid, which is a 28 percent sodium chlorite solution, with some acidic drink such as orange juice. Instead of providing healthy benefits, the liquid produces chlorine dioxide. That is the same sort of bleach used commercially to strip textiles and in water treatment plants. Consuming quantities of this type of bleach can also cause nausea, vomiting, diarrhea, and dehydration.

Consumers are directed by the FDA to dispose of MMS and to report adverse events to the MedWatch program at www.fda.gov/medwatch/report.htm Or 800-FDA-1088. Consult with a physician if you experience any side effects.

Besides the obvious dangers, the FDA reports in a news release that there is no evidence MMS can treat a common cold, cancer, HIV, hepatitis, swine flu virus, or any other condition MMS claims to treat.

Under Florida law, manufacturers, sellers and distributors of products that pose a danger to users may be held responsible for a defective design or manufacture of a product under products liability or negligence law. If you or a loved one has purchased this product, and have been harmed you may have a product liability action against the manufacturer and you should contact a Florida product liability attorney right away.

The federal agency is also considering civil or criminal enforcement actions to protect the public.

A new electronic early detection system utilized by the Food and Drug Administration logged 125 primary reports of unsafe food or animal feed in the first seven months of operation, keeping the potentially dangerous food out of the mouths of consumers, according to PR Newswire.

Mandated by Congress, the Reportable Food Registry requires manufactures, processors, packers and distributors to report any safety problems with food for humans and pets, and animals. The reports help the FDA locate hazardous foods in the supply chain.

Notable cases so far include:

• In February 2010 – Hydrolyzed vegetable protein HVP was recalled, even though there were no reports of illness. More than 1,000 reports from industry on products with HVP led to the removal of 177 food products from store shelves.
• In November 2009 – Foods containing sulfites were recalled because they were not properly labeled. That led to the removal of two nationally distributed side dishes. Again there were no reports of illness.
• Salmonella was present in 37 percent of the 125 hazardous reports.
• Undeclared allergens were found in 35 percent of recalled food products.
• Listeria monocytogenes, a virulent food-borne pathogen and bacterium, made up 13 percent of reports.
• Among reports – There were 14 for animal feed or pet food; a dozen for seafood; 11 for spices and seasonings; and 10 for dairy products.

The legislation creating the food registry in 2007 requires industry to report any food for animals or humans that could reasonably present a probability of serious adverse health consequences or death. The reporting has to be done within 24 hours of the discovery of the problem and must be relayed to the FDA. Dietary supplements and infant formula do not have to be reported because they fall under a different mandatory reporting system. Also exempt are drugs and medical products or reports from consumers.

Interestingly any indication that a food product has been contaminated sparked a suspicion that it could be intentional, and the FDA must immediately notify the Department of Homeland Security. Florida food recall lawyers can help those who have experienced illness or harm from consuming contaminated food products.