FDA Plans Greater Public Transparency

Food and Drug Safety Goes See-Through?

This week, the U.S. Food and Drug Administration (FDA) announced the formation of a new task force that will examine the agency's policies and practices when it comes to making information public. The task force will make recommendations on how the FDA can improve the transparency of its operations and decision-making processes.

What sorts of changes can consumers expect through the FDA's new looking glass? Here's a look at some highlights of the FDA Transparency Task Force's plan:

• Identify what agency information and actions should be opened up to the public, and what needs to remain confidential.
• Explore ways the agency can better explain its operations to the public, including specific enforcement actions and and product approvals.
• Eliminate the barriers (internal and external) to providing useful and understandable FDA decision-making information to the public.
• Improve current FDA policies to better provide timely information to the public, including the identification of new tools and technological avenues that can be utilized to provide updates on FDA actions, both pending and in progress.
• Recommend legislative or regulatory actions that can improve the FDA’s ability to provide information to the public.

On the heels of the announcement of the new FDA Transparency Task Force, the FDA also scheduled a June 24 public meeting to hear recommendations on how the agency can better provide "useful and understandable information on its activities and decisions," according to the FDA News Release.

The Wall Street Journal reports that the new task force will seek to combat the FDA's reputation as a "black box that makes important decisions without explaining them," as FDA Commissioner Margaret Hamburg put it." Topics likely to be on the table include clinical-trial data and details on decisions about recalls and drug approvals," according to the WSJ. 

• News Release: FDA Forms Transparency Task Force (FDA.gov)
• FDA Transparency Task Force (FDA.gov)
• Wall Street Journal Health Blog: FDA Tries to Decide What Should, Shouldn't Be Kept Secret
• N.Y. Times Editorial: FDA's Secret Files
• Legal Questions and Answers (provided by Law Offices of Jack Bloxham)
• Products and Legal Issues (provided by Bernard & Stuczynski)  

Swine Flu Treatment Scam Warning Issued by Feds

As news about the H1N1 influenza (swine flu) virus continues to grab headlines and attention around the globe, it's no surprise that some shady characters are looking to cash in on public fears over the outbreak. U.S. health officials are warning consumers to be on the lookout for the online (and offline) promotion of products that promise to diagnose, prevent, treat, or cure the virus.

The U.S. Food and Drug Administration (FDA) reports that the fraudulent H1N1 treatment products being offered by scammers "come in all varieties and could include dietary supplements or other food products, or products purporting to be drugs, devices or vaccines." FDA warns consumers that these products "will not prevent the transmission of the virus or offer effective treatments against infections caused by the H1N1 influenza virus."

The FDA reminds Americans that only two antiviral medications have been approved by the agency for treatment of the H1N1 influenza (swine flu). The approved medications are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). FDA advises consumers to "contact their health care providers or legitimate medical supply services if they have questions or concerns about medical products or personal protective equipment."

Reuters reports that the H1N1 influenza scams have included a blitz of phony websites and "spam" emails, including one scam email offering a "'Flu Safety Kit' that contains facial tissues, disinfecting wipes and alcohol-based hand sanitizer."

• FDA Warns Public of Fraudulent 2009 H1N1 Influenza Products (FDA.gov)
• 2009 H1N1 (Swine) Flu Virus (FDA.gov)
• Reuters: Another Outbreak? Experts Warn of Flu Scams
• L.A. Times: Swine Flu Scammers Selling Fake Remedies Online
• Health Care Law: Articles, FAQ, and More (FindLaw)
• Products Liability (provided by Randy W. James & Associates, P.C.) 

FDA Approves Plan B "Morning After" Pill for 17-Year-Olds

The emergency contraceptive Plan B "morning after" pill will soon be made available over-the-counter to 17-year-olds, federal health officials announced yesterday.

The announcement from the U.S. Food and Drug Administration (FDA) came one month after a federal court slammed the agency's handling of the approval process for the Plan B "morning after" pill (levonorgestrel), and basically ordered that the drug be made available to 17-year-olds over-the-counter (as it is currently available to women 18 and older).

As Reuters reports, a U.S. district court judge ruled in March that the Bush administration's FDA "had allowed politics to cloud its decision-making process regarding availability of the Plan B drug which had been restricted to those 18 and older."

In accordance with that court order, the FDA declared yesterday that "the government will not appeal this decision... FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

The Plan B "morning after" pill (levonorgestrel) is "is a set of two pills that contain higher doses of progestin than are used in prescription birth control pills," and is manufactured by Barr Pharmaceuticals Inc, (now part of Teva Pharmaceutical Industries Ltd.), according to Reuters. The Plan B pill received FDA approval as a prescription drug in 1999, and was cleared for over-the-counter sales in 2003. The following years saw a great deal of back-and-forth among lawmakers, drug manufacturers, and interest groups on both sides of the contraception debate. See a Timeline of Key Dates in the Morning After Pill Controversy, from Reuters.     

• Updated FDA Action on Plan B (FDA.gov)
• Plan B (0.75mg levonorgestrel) Tablets Information (FDA.gov)
• Reuters: FDA Eases Access to Morning-After Pill
• Reuters: Timeline of Key Dates in the Morning After Pill Controversy
• Judge Tells FDA to Make a Plan B for Teen Use of Morning After Contraceptive Drug (FindLaw's Common Law)
• Patient Rights and Responsibilities (provided by Patton Law Practice) 

Survey: Many Consumers Ignore Food Recalls

Many U.S. consumers don't check their homes for products that have been recalled and linked to food contamination, despite the amount of media attention paid to recent high-profile food recalls that have been tied to a salmonella health scare.

The study by the Food Policy Institute at Rutgers University was conducted via phone interviews with 1,101 consumers in 2008. While most consumers in the survey reported paying a "great deal of attention" to food recalls, "40 percent of these consumers think the foods they purchase are less likely to be recalled than those purchased by others, appearing to believe that food recalls just don't apply to them," according to a Press Release from Rutgers University.

Food safety has become a key concern of public health officials and lawmakers in recent weeks. A food safety report released last week by CDC shows little progress in fighting foodborne illness cases in recent years, and in the last few months consumers have been deluged with announcements of the recalls of hundreds of peanut butter products and food items containing pistachio nuts, over links to salmonella contamination.  

According to estimates from the Centers for Disease Control and Prevention (CDC), about 76 million people get sick from food each year, with 325,000 of those requiring hospitalization for their illness, and 5,000 people each year dying from food poisoning, Reuters reports.

• Rutgers Study Finds Many Consumers Ignore Food Product Recalls (Rutgers University)
• Food Policy Institute at Rutgers University
• Reuters: Many Americans Ignore Food Recalls: Survey
• Food Poisoning and the Law (FindLaw)
• Food Safety Resouces (FindLaw)
• What is Salmonella? (FindLaw)

List of Recalled Pistachio Products Grows as Salmonella Probe Continues

The U.S. Food and Drug Administration (FDA) is reminding consumers that the recalled pistachio product list continues to expand as an agency investigatation seeks to pinpoint the source of salmonella contamination in pistachios.

In late March, the FDA, supplier Setton Pistachio of Terra Bella, Inc., and retailer Kroger Foods announced two separate and large-scale recalls involving pistachio nuts and products containing pistachios, because of possible salmonella contamination. Since then, the list of pistachio product recalls has been growing steadily, with 250 products now on the FDA's Updated Pistachios and Pistachio Products Recall List. In addition to raw and roasted pistachio nuts (in-shell and shelled), affected products include candy, ice cream, and snack food products.

The FDA offers the following advice to consumers: "Consumers should not eat pistachios or food products containing them (such as pistachio bakery goods and pistachio ice cream) until they can determine that the products do not contain pistachios recalled by Setton."

The New York Times reports that earlier this week, Setton (the second-largest pistachio processor in the U.S.) agreed to expand tenfold an earlier recall so that it includes the coompany's entire 2008 crop of pistachios, likely meaning that "hundreds of pistachio-containing food products, like trail mix and nutty chocolate bars, will be recalled in the coming weeks."

• FDA Pistachio Product Recall Spotlight Page (FDA.gov)
• Updated Pistachios and Pistachio Products Recall List (FDA.gov)
• FDA Answers Consumer Questions About Pistachio Products (FDA.gov)
• Washington Post: As Food Recalls Continue to Sprout, What Can a Consumer Do?
• N.Y. Times: Pistachio Recall Signals Tough Stance on Safety 
• What is Salmonella? (FindLaw)
• Food Poisoning: Health and Legal Information (FindLaw)

House Votes for FDA Power to Regulate Tobacco

The U.S. House of Representatives has voted to give the Food and Drug Administration (FDA) the authority to regulate the production, sale, and advertising of tobacco products, including cigarettes.

The House gave its approval to the FDA's oversight of tobacco by a 298-112 vote. Reuters reports that the bill "would give the FDA a range of authorities over the multibillion-dollar tobacco industry," including the power to "restrict advertising to children, require larger package warnings and force companies to lower -- but not eliminate -- nicotine content."

Next up for the bill is a Senate vote, where a battle looms, according to the New York Times. And if the measure passes there, it will make it to President Obama's desk for signature or rejection.

Cigarettes have been the controversial focus of personal injury and product liability cases for decades. In a number of high-profile lawsuits, the family members of deceased smokers have sued tobacco companies for knowingly marketing deadly products, and some plaintiffs have claimed that tobacco companies defrauded them into thinking light cigarettes were safer than regular cigarettes.

Some tobacco litigation cases have led to huge damage awards over smokers' deaths. Just this week, the U.S. Supreme Court turned away an appeal by tobacco industry giant Philip Morris, which sought to overturn a $79.5 million punitive damages order awarded to the widow of an Oregon cigarette smoker. 

Earlier this week, a federal tax increase on cigarettes took effect, raising the federal tax per pack from 39 cents to $1.01. 

• Reuters: U.S. House Votes to Grant FDA Authority Over Tobacco
• N.Y. Times: House Passes Tobacco Bill, But Senate Battle Looms 
• About the U.S. Food and Drug Administration (FDA.gov)
• What FDA Regulates | What FDA Doesn't Regulate (FDA.gov)
• Philip Morris Appeal of $79.5M Punitive Damage Award Rejected (FindLaw's Injured Blog)
• Light Cigarettes: Health Issues and Lawsuits (FindLaw)
• Smoking in the Workplace (FindLaw)
• Cigarette Tax Increase Has Smokers Coughing It Up (FindLaw's Common Law Blog)

FDA to Consumers: Don't Eat Pistachios

Two separate and large-scale recalls involving pistachio nuts have been announced in the last few days, due to possible salmonella contamination. And because the extent of the problem is net yet know -- including the specific products affected -- the U.S. Food and Drug Administration (FDA) is telling consumers to avoid eating pistachio nuts and any products containing them.

On Tuesday, Setton Pistachio of Terra Bella (California) issued a nationwide recall of about 1 million pounds of pistachio nuts, after salmonella was found in roasted pistachios that were used in certain brands of trail mix. Get more information on the Setton Pistachio recall from the California Department of Public Health.

Last Friday, The Kroger Co. announced that it was recalling "Private Selection Shelled Pistachios" sold in its various retail stores because of possible salmonella contamination. According to the FDA, "stores under the following names in the 31 states where Kroger operates are included in this recall: Kroger, Ralphs, Fred Meyer, Fry's, King Soopers, Smith's, Dillons, QFC, City Market, Foods Co., Jay C, Scott's, Owen's, Baker's, Gerbes, Hilander and Pay Less." Get detailed information on the Kroger Co. pistachio recall -- including affected products, stores, and states -- from the FDA.

People infected by salmonella bacteria can develop symptoms like diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most persons recover without treatment. But occasionally, symptoms may be so severe that hospitalization is necessary. The elderly, infants, and those with impaired immune systems are more likely to have severe illness. Learn more about salmonella and food poisoning.

• Setton Pistachio of Terra Bella Recall Information (California Dept. of Public Health)
• Kroger Co. Pistachio Recall Information (FDA)
• WebMD: FDA: Stop Eating Pistachios, Salmonella Feared
• Reuters: Pistachios Recalled Due to Salmonella Risk
• FDA Guidelines for Recalls (provided by The Epstein Law Firm)
• What is Salmonella? (FindLaw)
• Food Poisoning: Health and Legal Information (FindLaw)

Cigarette Tax Increase Has Smokers Coughing It Up

If you're a smoker, now may be a good time to try to kick the habit, because a bump in the federal tax on cigarettes goes into effect this week, raising the federal tax per pack from 39 cents to $1.01.

The increase in the federal tobacco tax is a part of the Children’s Health Insurance Program Reauthorization Act of 2009, which was signed into law in February. The Act calls for an increase in the federal excise taxes on all tobacco products, including cigarettes, cigars, rolling papers, and chewing tobacco. The federal tax on a pack of cigarettes will be over $1.00 as of April 1st, and anyone buying a carton of cigarettes will end up paying over $10 in federal taxes.

According to the Wall Street Journal, both tobacco companies and anti-smoking groups are trying to angle the tax hike to their advantage: "Major cigarette makers raised prices in recent weeks, partly to offset any drop in profits once the per-pack tax climbs from 39 cents to $1.01. Medical groups, meanwhile, see a tax increase in the middle of a recession as a great incentive for smokers to quit."

• Federal Tobacco Excise Tax Increase (Alcohol and Tobacco Tax and Trade Bureau)
• Tobacco and Taxes FAQs (Alcohol and Tobacco Tax and Trade Bureau)
• Wall Street Journal: Smokers Prepare for Tax Hit
• Consumer Taxes: State-by-State Laws (FindLaw)
• Consumer Issues and the Law (FindLaw)

Judge Tells FDA to Make a Plan B for Teen Use of Morning After Contraceptive Drug

The AP reports that a federal court judge has dealt the Food and Drug Administration (FDA) a stinging rebuke over its handling of the approval process for the Plan B morning-after pill during the Bush administration. The Plan B drug, sold by Barr Pharmaceuticals (acquired by Teva Pharmaceutical Industries), is a contraceptive pill that "reduces the chance of pregnancy if taken within three days after sex."

According to U.S. District Judge Edward Korman's ruling, politics improperly infected the agency's decisionmaking when it "repeatedly and unreasonably" delayed issuing a decision on the drug. The AP further quoted the judge:

"Korman's ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions took action only to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.

'These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making,' Korman said. 'Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.'"

As a result of the findings, the judge has ordered that the Plan B drug be made available to 17-year-olds without a prescription, in the same manner that the medication is currently available to women over the age of 18.  Noteably, the court also left untouched various constitutional issues raised in the case.

According to the AP, the FDA had argued in court filings that "politics played no role in the agency's decisions." However, the evaluation of the drug has been plagued by reports of politics and/or religion affecting the entire process. Despite the 30 days that today's order gives the government for compliance, a government attorney has indicated that the agency is "studying the decision and evaluating options". At the same time, it also remains to be seen what effect, if any, the change in administration plays in a further review of the drug.

• AP: Judge orders FDA to let 17-year-olds use pill
• District Court's Opinion (FindLaw)
• Reuters: US court tells FDA to rethink Plan B contraceptive
• FDA Drug Approvals Index (FDA Center for Drug Evaluation and Research)
• FDA Overview (provided by Goldenberg & Johnson, PLLC)
• Washington Post: FDA Approves Plan B's Over-the-Counter Sale
• Washington Post: FDA Official Quits Over Delay on Plan B
• 60 Minutes: The Debate Over Plan B: Did Religion Play Role In An FDA Decision? (CBSNews.com)

Smoking Smarties the Next Hazardous Fad for Kids?

Most people are probably familiar with the little rolls of powdery, sugary candy "tablets" frequently given out at Halloween. Yes, we're talking about "Smarties", but the little candy has been making unwelcome news headlines lately, with stories of kids "smoking" the candy.

Apparently, the practice isn't really so much "smoking" (there's no fire involved), as much as snorting or inhaling and then blowing out candy "smoke". Kids have taken to this practice for a variety of misguided reasons. One teen told the Wall Street Journal that "smoking Smarties [is] a 'cultural phenomenon' and says he likes it because 'it looks like you're smoking something but you're not.'" One YouTube user thought of it more as a prank, "To freak your mom out, sit behind a chair and just blow smoke up in the air with your mom in the room."

The WSJ described how kids go about smoking Smarties as follows:

"They crushed it into a fine powder in its wrapper, tore off one end, poured the powder into their mouths and blew out fine Smarties dust, mimicking a smoker's exhale."

That doesn't sound exceedingly alarming at first glance, but health experts say that "smoking" smarties is not too smart. A Mayo Clinic nose specialist "cautioned that frequent use could lead to infections or even worse, albeit rare, conditions, such as maggots that feed on sugary dust wedged inside the nose." It's probably tough for parents to come up with something more effective to convince their kids not to try this fad than by telling them they could end up with maggots up their nose.

Although a quick online search doesn't turn up any noteable injuries associated with smoking Smarties for purposes of legal liability, the candy's maker, Ce De Candy of New Jersey, is still not thrilled with this kind of publicity. The company's vice president of sales and marketing, Eric Ostrow, told the WSJ that smoking their product is "just dumb." However, the Business Insider also noted just how easy it is for an undesireable fad to catch fire in today's social-media world. Even though many of the YouTube videos were made long ago, it is only recently that one "video now appears near the top of the Google results page in a more general search for just 'Smarties.'" Ostrow continued, "It's certainly not endorsed by us. We don't endorse smoking, but we can't control what people do out there."

Companies face a tough task in how they deal with their brand and/or product being associated with an undesireable practice, such as smoking (which Ce De Candy actually banned at its factory in the 1980s, well ahead of its time). Although many might say that any PR is good PR, the association of kids, candy, and smoking might be a bit much. But for now, the company is apparently opting to simply disassociate itself with the practice and hope that the whole issue will blow over.

On the bright side, recent news stories have highlighted a government study noting that "[f]ewer teens are sniffing glue, lighter fluid, spray paint, shoe polish and other easy-to-find substances." Regardless, parents still might want to go ahead and just give their kids a heads up to be smart and just eat their Smarties.

• Wall Street Journal: Just Say No....to Smarties? Faux Smoking Has Parents Fuming
• Business Insider: Candy-Maker Tries To Ignore Kids Pretending To Smoke On YouTube [with Videos]
• Products Liability FAQ (provided by Hefferon & Hefferon, P.A.)
• AP: Fewer teens sniffing inhalants to get high (WRAL)