In Wake of Pilva V. Mensing, an Uproar: FDA's New Proposed Rule Would Let Generic Drug Makers Update Their Warning Labels

In 2012, the U.S. Supreme Court ruled in the case of Pilva, Inc. v. Mensing that the makers of generic pharmaceuticals cannot update their warning labels independently. This proscription holds, even when new, dangerous side effects of a medication are found. Drug makers cannot add those dangers to their labels by themselves.

Pilva v. Mensing was an interesting, subtle case, but critics argue that the SCOTUS ruling created a loophole that put thousands of Americans at risk and unfairly limited their legal recourse. They say it created a de facto "two tiered" system -- one set of rules for updating warning labels on brand drugs and another set of rules for updating labels on generics. This system needlessly confuses people and lacks accountability.

Consider this fact: 80% of prescriptions filled in the United States are generic. That’s four out of every five prescriptions filled. Since Pilva, thousands of people hurt by side effects of generic drugs have been unable to have their day at court.

Recognizing this insanity, in November 2013, the FDA proposed a new rule to let generic drug makers revise warning labels when new side effects are discovered. This amendment to the process would effective end the annoying and unfair de facto "two tiered" system.

The American Association for Justice (AAJ) supports the FDA’s proposed guidelines. AAJ president, Burton LeBlanc, noted that “the proposed rule takes account of both the need for accurate warnings and the need for the sameness and proposes regulatory changes that will [further] both of those goals… [It] will make consumer safety information work accessible and available sooner… In addition, the proposed rule will ensure that generic pharmaceutical manufacturers are responsible, if they fail to warn the public of a known safety hazard associated with their products.”

Consumer advocates want the FDA to push this rule through, ASAP, and they've created an online petition to get the FDA to act. This petition already has over 20,500 signatures.

The proposed rule changes would constitute a good start towards cleaning up the regulatory environment and making systems less complex for consumers and doctors. However, tons of work still needs to be done. Regulatory authorities are often shamefully slow to react the dangerous, careless, and negligent behavior of drug makers and pharmaceutical companies. Their sluggishness can leave injured consumers confused, overwhelmed, and sick -- forcing them to engage in lengthy, fractious, expensive legal processes to get justice.

If you or someone you love was hurt by a generic pharmaceutical drug, the Washington D.C. personal injury lawyers at Regan Zambri & Long would be happy to provide a free and confidential consultation about your case. Call us now at (202) 463-3030 for much needed strategic insight.
 

GM Recall Delay Prompts Multiple Investigations

Posted by: Salvatore J. Zambri, founding member and partner

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Reports show that General Motors knew that faulty ignition switches were a serious and potentially deadly defect in their automobiles as early as 2004. However, those vehicles were not recalled until February, 2014. The faulty ignition switches shut off without warning, leaving the vehicles with no power steering, brakes or air bags. To date, GM has acknowledged that 12 deaths were caused by this problem, although the Center for Auto Safety estimates that the number of deaths is closer to 300.

As a result of delayed recall, multiple investigations by General Motors and several government agencies are now under-way. The National Highway Safety Administration (NHTSA) notified GM earlier this month about its investigation. Critics are questioning why NHTSA did not initiate investigations many years ago, when the first deaths were reported.

In addition, the Department of Justice will be opening an investigation to determine whether GM is legally liable for the incidents that occurred prior to GM's bankruptcy because of the late recall. The U.S. House Energy and Commerce Committee will be opening a similar investigation soon. GM's new CEO is scheduled to testify about the late recall on April 1, 2014.  The Senate's Consumer Protection Subcommittee is also planning a hearing for April 2, 2014 for the purpose of "Examining the GM Recall and NHTSA's Defect Investigation Process."

Whether General Motors' bankruptcy and federal bailout in 2009 will prevent any legal responsibility for any incidents before June 1, 2009 is an important issue to resolve. Depending on the results of the criminal investigation, if it is determined that the company defrauded the court by withholding information about the safety defect, GM may be held liable for injuries and deaths from the ignition problems that occurred before the bankruptcy. Experts are divided as to whether the bankruptcy will provide immunity from criminal prosecution.

As I have blogged previously, putting profits above the safety of consumers seems to have become an acceptable part of the business plan for some corporations. Let's hope this trend reverses as enough people speak out about the dangers of overlooking or minimizing safety.

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Huge News: Florida Supreme Court Overturns Law Limiting Damages in Wrongful Death Claims

Did you recently lose a loved one in an accident or due to someone's negligence or carelessness? If so, a recent decision rendered by the Florida Supreme Court could have major implications for your wrongful death case.

Putting a price on a human life is never an easy proposition. The moral, ethical, even philosophical implications are profound. Yet the law still needs guidelines to regulate the process of wrongful death claims.

In its recent decision, the Florida Supreme Court drove a stake through the heart of a 2003 Florida law that had been designed to overhaul medical malpractice suits. The court rightfully bashed the legislature for confabulating an alleged "medical malpractice crisis" in Florida. The idea that “too many frivolous lawsuits” needlessly burden good physicians and hike up medical insurance liability premiums may sound good on paper to some people. But the evidence just isn’t there to support this hypothesis.

The Supreme Court said as much: “…the finding by the Legislature and the Task Force that Florida was in the midst of a bona fide medical malpractice crisis, threatening the access of Floridians to health care, is dubious and questionable at the very best."

The Court then (also, rightfully) laid the blame on high premiums on the insurance companies themselves. It noted that, since the 2003 legislation passed, four insurance companies that specialize in medical malpractice products saw their net income rise by 4,300 percent.

That's not a typo. Their income rose by 4,300 percent!

The Supreme Court offered a commonsense suggestion: “the insurance industry should pass savings onto Florida physicians in the form of reduced medical malpractice insurance premiums.”

The 5-2 decision, written by Justice R. Fred Lewis, will end the cap on “non-economic” damages in wrongful death suits due to medical malpractice. Analysts said the 2003 law wasn’t fair because it treated someone hurt by medical malpractice differently than someone hurt due to other types of negligence or wrongful actions.

The case involved a 20-year-old woman, Michelle McCall, who bled to death after a C section at a Fort Walton Beach Hospital. McCall had been a member of a military family, so her estate was able to sue the federal government in the wrongful death case. Her estate would have been awarded $2 million in non-economic damages, but the court limited the award to just $1 million, per the 2003 law.

The estate appealed. The 11 U.S. Circuit Court of Appeals in Atlanta found the damage limits Constitutional. But the Florida Supreme Court said, in effect, "not so fast," noting that Florida state Constitutional issues needed to be considered as well.

Judge Lewis had scathing language for the 2003 law: “The statutory cap on non-economic damage fails because it imposes unfair and illogical burdens on injured parties when an act of medical negligence gives rise to multiple claims… there is no rational relationship to a legitimate state objective.”

And as for the insinuation that Florida had been in a state of “unprecedented crisis” regarding med mal, Lewis referred to statistics that demonstrated “the number of physicians in Florida were actually increasing, not decreasing” at the time of the 2003 bill's passage and that “even the task force whose report was relied upon by the Florida Legislature employed extremely equivocal language and speculation when describing the existence of crisis.”

It makes tons of sense that the Court struck down this eccentric and mean spirited law on equal protection grounds.

For a free, confidential consultation about your D.C. wrongful death case, connect with the team at Regan Zambri and Long today at (202) 463-3030.
 

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Do Skiers and Snowboarders Need Helmets?

Posted by: Salvatore J. Zambri, founding member and partner

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The recent high-profile skiing accident of Formula-One World Champion Michael Schumacher's has re-ignited the long-standing debate over the necessity of wearing helmets while participating in winter sports.

Should skiers and snowboarders wear helmets? Outdoor winter sports allow speed and an adrenaline rush that appeals to many. Predictably, higher injury risks accompany those higher speeds. Skiers and snowboarders generally travel at speeds that are much faster than the average bicyclists. Bicyclists are becoming more accustomed to wearing helmets and many states have mandated their use. A number of published studies indicate that the incidences of serious brain injuries or deaths in ski collisions are increasing. However, owners and operators of snow sports resorts do not require helmet use, rationalizing that the decision should should be an individual choice.

In addition to the obvious risks associated with skiing and snowboarding, participants in other winter sports should understand the dangers of not wearing helmets, especially for children. For example, snowmobiles can reach speeds of over 100 miles per hour. With children as young as eight years old allowed to drive them and no state helmet laws, the risks of serious accidents and head injuries increase. Even sledding and tobogganning have their share of collisions. 

Increased helmet use for winter sports in recent years has directly had an effect in protecting users injuries, ranging from lacerations to skull fractures. However, evidence indicates that helmets are not able to offer enough protection against more serious injuries such as "tearing of delicate brain tissue," according to Jasper Shealy of the Rochester Institute of Technology. Although helmet manufacturers are working to make helmets safer, some medical professionals actually believe that wearing a helmet can give skiers and snowboarders a false sense of security. Experts tend to believe advanced equipment and resorts creation of more extreme terrains allows more risk-taking behaviors.

"The American Academy of Orthopaedic Surgeons (AAOS) recommends the following safety guideline to improve winter sports safety: 

  • Parents or adults should supervise young children during all winter downhill slope sports activities at all times.
  • Avoid slopes that end in a street, gravel road, drop off, parking lot, river or pond.
  • Make sure people at the bottom of the slope have cleared the slope path prior to allowing another sled to go down the slope.
  • Use well-lighted areas when choosing evening activities.
  • To protect from injury, it is important to wear helmets, gloves and layers of clothing.
  • Helmet Use
    • The National Ski Patrol recommends wearing a helmet while skiing or snowboarding. Studies show that helmets offer considerably less protection for serious head injury to snow riders traveling more than 12-14 mph. Safety and conscientious skiing and riding should be considered the most important factors to injury prevent, while helmets provide a second line of defense against head injuries.

• Sledding

    • All participants should sit in a forward-facing position, steering with their feet or a rope tied to the steering handles of the sled. No one should sled headfirst down a slope.
    • Do not sit/slide on plastic sheets or other materials that can be pierced by objects on the ground.
    • Use a sled with runners and a steering mechanism, which is safer than toboggans or snow disks.

• Snowboarding and Skiing

    • Warm-up the muscles that will be used in skiing with exercise activities to help prevent injury such as knee lifts, heel raises, abdominal twists and squats. When done, take a few minutes to stretch out your muscles (hamstrings, arms and calves).16
    • Use proper ski and snowboard equipment such as properly fitting boots and adjusted bindings that attach the boots to the skis/snowboard—bindings are set to skier classification, height and weight and should only be set by a certified technician to help prevent injuries during a fall.
    • Participants should ski on trails within his or her skill level.
    • Obey trail closure and other warning signs. Do not go off-trail.

Individuals with pre-existing neurological problems may be at higher risk for injury. If you have a pre-existing condition, you should talk to your doctor before participating in these activities."

As with any behavior that is inherently risky, participants should exercise common-sense behavior and use whatever safety equipment is available to them. Wearing a helmet should not be used as an excuse to engage in overly-extreme or unnecessarily dangerous behavior.

Be safe.

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A New Distracted Driving Trend - "Selfies"

Posted by: Salvatore J. Zambri, founding member and partner

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When does creativity become insanity? Distracted driving has now reached a new level among young drivers. The newest alarming trend is taking self-portraits - "selfies" - while driving. Some drivers even add #Ihopeidontcrash with their photos. Such a hashtag indicates that the driver is aware of how dangerous this practice is. Apparently, that awareness does not extend to a realization that it is too dangerous to attempt. The popularity of Instagram, Twitter, texting and other social media as well as peer pressure seem to tempt young drivers into irresponsible behavior while driving. The rationale that taking a photo or texting only involves a few seconds fails to recognize that is also the same amount of time it takes to cause a serious collision. 

Distracted driving has already alarmed highway-safety groups, governments, and law enforcement, as indicated by high-profile promotions against distracted driving as well as many new state laws making distracted driving a primary offense.

Among safety advocates, a statement by the president of Advocates for Highway and Auto Safety says, "Taking a photo of yourself while you're driving down the road at 50 or 60 miles per hour? That is putting your life in danger and putting the lives of those around you in danger. . . . Driving is a really serious thing."

According to the Department of Transportation, more than 3,300 deaths are caused each year by distracted driving. The National Highway Traffic Safety Administration (NHTSA) has targeted its promotions against distracted driving toward teens and young adults. The leading cause of deaths among teenagers is car crashes.

  • "In 2011, over half of the teen occupants of passenger vehicles who died in crashes were unrestrained;
  • Speeding was a factor in 35 percent of fatal crashes involving a teen driver;
  • Twelve percent of teen drivers involved in fatal crashes were distracted at the time; and
  • In 2011, 505 people nationwide died in crashes in which drivers between 14 and 18 years old had alcohol in their systems, despite the fact that all states have Zero Tolerance Laws for drinking and driving under age 21."

I represent victims of distracted-driving every day in my law practice. I also routinely give presentations to local schools on the issue of distracted driving, a growing concern among drivers of all ages, but especially teen drivers. Please be careful on the road and don’t hesitate to contact me if you would like to learn more about my presentations concerning distracted driving. You can call me at (202) 822-1899 or email me at szambri@reganfirm.com.

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College Binge-Drinking: Is It a Problem? If So, What Is Being Done to Curtail It?

Posted by: Salvatore J. Zambri, founding member and partner

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Listed below area few catchy phrases associated with binge drinking among college students:

  • YOLO - You only live once;
  • Twenty-one for twenty-one - 21 drinks for 21st birthday;
  • Fourth-year fifth - finishing a fifth before kickoff at the final home football game.

According to the National Institute of Alcohol Abuse and Alcoholism, a division of the National Institutes of Health (NIH), "Research shows that more than 80 percent of college students drink alcohol, and almost half report binge drinking in the past 2 weeks."  Out-of-control drinking can lead to much more serious consequences than missing classes due to a bad hangover the next day. 

Some of the consequences of abusive college drinking include death, injury, alcohol poisoning, assault, sexual abuse, unsafe sex, academic problems, alcohol abuse and dependence, and drunk driving. Statistics associated with college drinking include:

  • ". . . an estimated 1,825 college students between the ages of 18 and 24 die from alcohol-related unintentional injuries, including motor vehicle crashes.
  • . . . an estimated 599,000 students between the ages of 18 and 24 are unintentionally injured under the influence of alcohol.
  • . . . an estimated 696,000 students between the ages of 18 and 24 are assaulted by another student who has been drinking.
  • . . . an estimated 97,000 students between the ages of 18 and 24 are victims of alcohol-related sexual assault or date rape.
  • . . . an estimated 3,360,000 students between the ages of 18 and 24 drive under the influence of alcohol."

College binge-drinking is a problem. Controlling high-risk binge-drinking on college campuses has always been challenging. One organization aimed at finding a solution to excessive college drinking is the Amethyst Initiative, launched in 2008 and signed by 136 college chancellors and presidents across the United States. "These higher education leaders have signed their names to a public statement that the problem of irresponsible drinking by young people continues despite the minimum legal drinking age of 21, and there is a culture of dangerous binge drinking on many campuses."

"The Amethyst Initiative supports informed and unimpeded debate on the 21 year-old drinking age. Amethyst Initiative presidents and chancellors call upon elected officials to weigh all the consequences of current alcohol policies and to invite new ideas on how best to prepare young adults to make responsible decisions about alcohol use."

Schools officials understand that drinking occurs both on and off campus, so their efforts are aimed at preventing excessive drinking and encouraging safe drinking. Some actions undertaken by schools include:

  • Offering more Friday classes;
  • Sponsoring frequent alcohol-free events;
  • Including mandatory alcohol education in orientation programs;
  • Establishing relationships with local businesses and police departments in dealing with on and off-campus drinking;
  • Initiating Amnesty and Good Samaritan programs for those who call emergency services;
  • Using campus health centers to teach students about the risks of drinking and how to monitor drinking and handle high-risk situations.

While arguments continue over the drinking age and other college-age student drinking concerns, many colleges have determined that it may be more productive to work towards educating students about responsible drinking rather than attempting to eliminate it.

In summarizing the dangers of binge-drinking, my goal is not to lecture but to present the facts about its dangers. Drinking is one thing; becoming out-of-control dangerous is something else. Please be responsible, and don't let anyone pressure you to binge-drink.

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"Vaping" Trend Among Middle & High School Students

Posted by: Salvatore J. Zambri, founding member and partner

  

A new and rapidly growing trend among middle and high school students is electronic cigarette use. Vaping is the term used by kids to describe using e-cigarettes. A battery powered atomizer produces a vapor of propylene glycol or vegetable glycerin based liquid, combined with nicotine and flavoring which is inhaled and exhaled similarly to cigarette smoke. E-cigarettes come in a variety of popular flavors such as bubblegum, chocolate, and various fruits. 

According to the National Youth Tobacco Survey results, in 2012, the increase in usage doubled among this age group, prompting concern among health officials. According to a spokesman for the American Lung Association,"People are inhaling some type of vaporized compound into their lungs without really knowing what's in it." Numerous health experts have indicated that the experiments raise many questions regarding the unknown impact on an adolescent brain. Surprisingly, even a chief executive of a producer of e-cigarettes said that the rise in youth usage was "unacceptable" and added that the company was "looking forward to a regulatory framework that restricts youth access."

In 2009, the FDA warned that e-cigarettes could pose health risks. Currently, the FDA is conducting "listening sessions" and is expected to publish proposed regulations in October, 2013.

According to the Centers for Disease Control and Prevention (CDC) in the Morbidity and Mortality Weekly Report (MMWR) released today, "Electronic cigarettes, or e-cigarettes, are battery-powered devices that provide doses of nicotine and other additives to the user in an aerosol. Depending on the brand, e-cigarette cartridges typically contain nicotine, a component to produce the aerosol (e.g., propylene glycol or glycerol), and flavorings (e.g., fruit, mint, or chocolate) (1). Potentially harmful constituents also have been documented in some e-cigarette cartridges, including irritants, genotoxins, and animal carcinogens (1). E-cigarettes that are not marketed for therapeutic purposes are currently unregulated by the Food and Drug Administration, and in most states there are no restrictions on the sale of e-cigarettes to minors. Use of e-cigarettes has increased among U.S. adult current and former smokers in recent years (2); however, the extent of use among youths is uncertain.

E-cigarette experimentation and recent use doubled among U.S. middle and high school students during 2011–2012, resulting in an estimated 1.78 million students having ever used e-cigarettes as of 2012. Moreover, in 2012, an estimated 160,000 students who reported ever using e-cigarettes had never used conventional cigarettes. This is a serious concern because the overall impact of e-cigarette use on public health remains uncertain. In youths, concerns include the potential negative impact of nicotine on adolescent brain development (4), as well as the risk for nicotine addiction and initiation of the use of conventional cigarettes or other tobacco products.

CDC and the Food and Drug Administration will continue to explore ways to increase surveillance and research on e-cigarettes. Given the rapid increase in use and youths' susceptibility to social and environmental influences to use tobacco, developing strategies to prevent marketing, sales, and use of e-cigarettes among youths is critical."

Please educate your children about the dangers of e-cigarettes.

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NFL and Former Football Players Settle Concussion Lawsuits

Posted by: Salvatore J. Zambri, founding member and partner

  

During recent NFL seasons, a main theme has been concussions and former players' lawsuits. Today's settlement of the lawsuit brought by former NFL players against the NFL for deliberately misleading players about concussion risks brings attention to the importance of taking concussions seriously. The settlement fund is intended to fund medical exams, concussion-related compensation and medical research. More than 4,500 former football players were plaintiffs in the case, many believing that their neurological problems were the results of on-field concussions.  In the lawsuits, they accused the NFL of hiding known risks of concussions. The NFL "has denied any wrongdoing and has insisted that safety always has been a top priority."

Hoping to avoid a repetitious need to constantly address the topic, the timing of the settlement allows the NFL to begin the new season with the issue resolved. 

With the concussion cases now settled, the questions about what the NFL knew and when it knew about concussion-linked brain problems will not have to be answered and the NFL's Mild Traumatic Brain Injury Committee inner-workings remain a secret. "... In a series of scientific papers from 2003 to 2009, members of the NFL's Mild Traumatic Brain Injury Committee wrote that 'no NFL player' had experienced chronic brain damage from repeated concussions." In 2005, the NFL series on concussions research concluded that chronic brain injury "has never been reported in American football players." The authors of the study, published in the medical journal "Neurosurgery," included three members of the NFL's Mild Traumatic Brain Injury Committee. 

While the NFL experts were denying a link between football and long-term brain damage, the NFL's retirement board concluded that players did suffer brain damage. According to a joint investigation by ESPN's "Outside the Lines" and PBS' "Frontline" show, the NFL retirement board began paying disability benefits to players in the late 1990s and 2000s, concluding that football caused their brain injuries.

According to the mediator, former U.S. District Judge Layne Phillips, this was "a historic agreement, one that will make sure that former NFL players who need and deserve compensation will receive it, and that will promote safety for players at all levels of football. Rather than litigate literally thousands of complex individual claims over many years, the parties have reached an agreement that, if approved, will provide relief and support where it is needed at a time when it is most needed."

"It's been a struggle to get to this point, but today I will say I'm very proud that the NFL has decided to stand up for all the former players who are suffering from brain injuries," said Kevin Turner, a former running back for the Philadelphia Eagles and New England Patriots, during a teleconference.

"Today is so important for those who are ... hurting. This will bring help for them today."

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Back to School - Make Safety Count

Posted by: Salvatore J. Zambri, founding member and partner

  

As school begins across the country, it seems appropriate to revisit some of the many blog entries we have posted over the years with the goal of educating children and their parents of the need for safety awareness. With new schools, inexperienced teen drivers, challenging sports activities, and temptations for "cool" activities, children face multiple safety issues on a daily basis. 

School safety begins with getting to and from school. The links below provide common-sense advice for any time of year. Reviewing these tips as school begins presents ideal teaching moments for parents.

Along with a new school year come new sports challenges and competitions. Sports are meant to make children stronger and healthier, not injure them. Adhering to all safety rules and regulations for sports activities should become part of the sport itself, not an afterthought.

Beginning a new school year also presents new opportunities for new temptations for children. Unfortunately, too many of those temptations are frequently associated with drugs or alcohol.  A couple of years ago, I posted a notice, More Reasons Why Teens and Alcohol Should Not Be Mixed, that I received from my children's school about how to talk with your child about setting appropriate boundaries. I am reproducing this notice again because I believe it provides an opportunity for parents to re-emphasize values, attitudes and expectations. By working together, schools, parents and students can create a safer environment.

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How Safe Are Drivers the Morning After Taking Sleep Aids?

Posted by: Salvatore J. Zambri, founding member and partner



Is there a possible link between sleep drugs and automobile accidents? Consumer advocates have long warned that there is. New evidence indicates that the effects of common prescription sleep aids do affect drivers the following day.  

The Food and Drug Administration (FDA) issued a consumer advisory in 2007 requesting that all manufacturers of sedative-hypnotic drugs strengthen their warning labels. By 2013, the FDA held additional sleep expert advisory committee meetings to determine the most effective labeling for sleep aids and whether banning direct-to-consumer advertising is advisable because of the possibility of next-day impairment. Residual next-day adverse effects were of concern, especially in dosing recommendations. Included in the discussions were phase three impaired driving studies in formal driving tests. One goal of the meeting was to decide how explicit labeling should be. As much labeling currently specifies, the burden is put upon patients to determine whether they are able to drive, when they are not necessarily reliable or able to determine that because of the drugs. As one of the clinical team leaders of the recent meeting indicated, "It would be so convenient and it would be so good if you could just tell people, don’t drive unless you feel O.K. I think this has penetrated now that this is not adequate. It is still good advice that, if you feel impaired, don’t drive. But if you feel fine, you might be impaired." 

Recently, the FDA has decided to further review all insomnia drugs on the market and ask manufacturers for more extensive driving tests for all new sleep drugs.  The agency also plans to more closely study any drug that causes drowsiness.

Since the White House Office of the National Drug Program has recently recommended that all states pass per se laws on drugs, states are left with the question of whether to include a prescription exception in their impairment laws. Although it has long been recognized that sleep deprivation and sleepiness lead to dangerous driving, it is important to also understand that the lingering side effects of taking a sleep aid may also lead to dangerous driving.  Many questions remain unanswered about the specifics of how individuals react to sleep aids, but a real danger does exist.

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