According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain.  Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to reduce the abuse seen with these painkillers.  The FDA would like to cut in half the number of prescription refills a patient can get before seeing their doctor, thus ensuring closer monitoring of both patients’ health and pharmaceutical requirements, allowing refills only for patients who truly require the drugs.

The FDA would also like to classify all prescription medications with hydrocodone as “Schedule II” medications.  The agency will begin to make that push next month, and will also seek to require that patients take their prescriptions to a pharmacy for refills, disallowing doctors the privilege of simply phoning prescriptions in.

In order for the recommendation to be used by the U.S. Drug Enforcement Administration, the U.S. Department of Health and Human Services must first approve the recommendation, and an FDA advisory panel held a vote which resulted in favor of the reclassification of hydrocodone.

The U.S. National Institutes of Health reports that one in five Americans have used prescription drugs in a recreational manner and since 2002, and that 22 million Americans have abused prescription painkillers in some way in the course of their lives.  NIH further reports that 47 million people were issued medications containing hydrocodone, filling around 131 million prescriptions.  The new classification will mean that less hydrocodone will be prescribed, and in turn, less available to be abused.  Patients will be required to visit the doctor’s office more frequently and the addition co-pays will increase health care costs.

Classifying hydrocodone as a Schedule II drug will allow the FDA to control hydrocodone in the same manner as other strong painkillers with high potential for abuse.  This push, however, is not only related to painkillers, and the ADD/ADHD drug Adderall would also face similar regulations.  The director of the agency’s Center for Drug Evaluation and Research has come out and explained that the push for this action has been driven by epidemic levels of prescription drug abuse.  Dennis Thompson of HealthToday.com believes that while the new changes may have some difficult implications for some people, the public health concerns have reached a point where something needs to be done.  I agree.

As of November 4th, Johnson & Johnson agreed to a $2.2 billion deal in the settlement of pending criminal and civil charges that “alleged the healthcare giant illegally marketed its Risperal antipsychotic [along with Invega and Natrecor], and also paid kickbacks to physicians and Omnicare, the largest nursing home/pharmacy [company in the US,] to boost prescriptions.” (pharmalive.com)

There are essentially two issues at play here.  First, Johnson & Johnson encouraged off-label use of several drugs.  This in itself is illegal, as the uses of drugs must be approved by the FDA.  Next is the issue of kickbacks – illegal greasing of pharmacies and physicians to sell more medications. J&J’s Risperal is approved by the FDA as an antipsychotic in the treatment of ailments like schizophrenia, but now it is revealed that the company paid doctors and Omnicare to prescribe the drug for the treatment of “anxiety, agitation, depression, hostility and confusion,” in elderly patients and young adults.

The US Department of Justice stated Monday that “In addition to imposing substantial monetary sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  This agreement is designed to increase accountability and transparency and prevent future fraud and abuse.”

DOJ continues: “‘J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,’ said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger.  ‘This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.’”

According to the New York Times, though the company “did not admit to any wrongdoing,” it has pled guilty to the illegal marketing of its products.  Let’s not analyze what it means if an entity pleads guilty to a crime and maintains that it did nothing wrong — does Johnson & Johnson believe illegal marketing of strong antipsychotics to children is morally acceptable?

David Ingram and Ros Krasny of Reuters reported Monday that other pharmaceutical giants have made similar settlements in recent years: “Pfizer Inc in 2010 agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs, including kickbacks to healthcare providers.

Last year, Britain’s GlaxoSmithKline Plc agreed to pay $3 billion to resolve criminal charges that it improperly targeted its Paxil depression treatment to children, sold its Wellbutrin antidepressant for unapproved uses and failed to inform U.S. regulators of safety risks seen with its Avandia diabetes drug.”

NY Times – In Oklahoma, a lawsuit surrounding a fatal car accident that injured an 82 year old woman and left a 70 year old woman named Barbara Schwarz dead, was settled on Friday between Toyota and the families of the two women involved.  For the first time ever, a jury found Toyota responsible for sudden acceleration of their vehicle that caused the crash.  Since Toyota could not show evidence that something other than a defect in the car caused the accident, the jury concluded that Toyota was responsible.  More than 11 million Toyota and Lexus vehicles have had problems such as floor mats causing the accelerator to become stuck, and these vehicles have all been recalled.  These millions of recalls were not great for the reputation of Toyota but despite the public embarrassment, Toyota reported its best earnings in the past five years.  There have been several lawsuits against Toyota recently.  In 2009 and 2010, $1.6 billion was given to Toyota vehicle owners who lost money from unintended acceleration.

Toyota claims it will not end its aggressive defense on all lawsuits against the company, especially the most recent incident involving the death of Barbara Schwarz.  Both sides of the suit are happy a mutually acceptable agreement was made and Toyota is hoping this will help their image of selling their customers safe vehicles.

Some legal experts state that recent verdicts against Toyota could give way to new cases going against the car company that can cost the company billions of dollars in recalls and lawsuits.  Each family of the two women from Oklahoma received $1.5 million in damages.  In this case, it was found that Toyota’s actions were reckless and their electronic throttle control system was flawed.

Toyota was recently cleared in a case involving a 66 year old woman who died when crashing her 2006 Camry, in which the jury decided that the blame should fall on the driver who hit the 66 year old woman and sent her car down the wrong way on a one way street.  The lawyer representing the family of the dead 66 year old women claims Toyota was responsible because they didn’t provide a brake override system.

While Toyota has avoided penalty for some of the accidents caused by defects in their cars, at least some of the victims of these accidents have won compensation.  Hopefully, Toyota takes the high road and fixes the problems with its vehicles’ acceleration so no one else gets hurt.

As reported by FDA News, the state of Maine has passed a law that green lights the use of imported prescription drugs through internet pharmacies.  The new law goes against past federal restrictions on drug imports that were established in order to inhibit the sale and use of medication that did not meet the federal standard.

Online pharmacies located in countries such as Australia and Canada are now able to sell their products in the United States.  These drugs are not properly screened by the FDA for their safety and often sold at a lower cost.  Some feel there is a problem with an individual state’s law that allows for the sale of prescription drugs through online pharmacies located in different countries because federal law supersedes state law.  So in this case, importing foreign pharmaceutical products could be considered illegal.  The U.S. Attorney General’s office and FDA declined to comment on the recent activity, and the executive vice president of pharmaceutical trade group PhRMA is worried that the pharmaceutical industry’s reputation is on the line.

The FDA had previously warned back in 2003 that the distribution of these online drugs from pharmacies that were based in foreign countries could expose American citizens to risky products – these drugs are being shipped from an unregulated source where the shipping methods are even under scrutiny.  Drug companies have been trying to develop a nationwide practice of accurate tracking and tracing of medications, and Maine’s new law would greatly inhibit this effort as medications would be coming from a completely different (international) system that operates independently.

In September, a lawsuit was filed seeking to stop the new law by PhRMA, the Maine Pharmacy Association, and other independent groups.  Some argue that a provision in the 1938 FD and C Act does not allow foreign drugs that are not properly screened and approved by the FDA to be sold in the United States.

This shows that the FDA is more interested in protecting pharmaceutical companies than patients.  Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk.  A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug.  And allowing any American to use the untested drug carries more risk than the dozens or hundreds of people who would be in a test.

 

Also, note that some of these drugs are generics.  Which means that individuals injured by drugs that weren’t even tested still can’t sue the manufacturer.  And of course, there is no “fraud on the FDA” claim available…

 

  • In 2011, the FDA announced years’ worth of studies from a major drug research lab were potentially worthless.
  • About 100 drugs were on the U.S. market based in part on these tests.
  • The FDA let the drugs stay on pharmacy shelves with no new testing (in some cases until now).
  • As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market.
  • The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed.
  • The FDA has never named the drugs, saying to do so would reveal trade secrets.
  • FDA Let Drugs Approved on Fraudulent Research Stay on the Market – ProPublica

    So, the Supreme Court will decide two interesting cases.  The one below will decide whether or not a brand name manufacturer can simply pay generic companies not to bring generic drugs to market:

    WASHINGTON (AP) — Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90 percent

    Source: The Associated Press: Court: Can drug companies pay to delay generics?

    The second is whether or not generic manufacturers can be held liable if their drugs injure consumers.  One of the arguments against letting generic manufacturers be sued is that they may take their products off the market due to the cost of litigation.  This is an entirely false argument if for no other reason than generic manufacturers can buy insurance that covers any payouts.

    But, if you accept the premise that it’s too important to make sure generic drugs are on the market to allow generic manufacturers to be sued, then you should also accept the premise that brand name companies shouldn’t be allowed to pay to keep generics off the market.  It will be interesting to see which justices rule which way on both cases.

    Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:

    Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does not mean, and should not be taken to mean, that a drug is absolutely safe even for approved uses,” said Mura, who wrote an amicus brief for AAJ in Bartlett. “Congress didn’t intend the FDA to provide the sole level of consumer protection, and a broad preemption ruling here would ignore that clear congressional intent.”

    Source:

    Supreme Court grapples with generic drugs and design defects

    On the one hand it’s disappointing to see them give up the fight.  On the other, at least this won’t lead to a SCOTUS ruling that strips the FDA of more power.  The fear of such a ruling is why I suspect the FDA gave up.

    (Reuters) – The government has dropped its push for cigarette labels to carry images of diseased lungs and other graphic health warnings, and will craft new anti-smoking ads that do not run afoul of free speech rights.

    In a letter to Republican House Speaker John Boehner last Friday, Attorney General Eric Holder said that the Food and Drug Administration would go back to the drawing board to develop the ads, as required by legislation passed by Congress in 2009.

    Source: Government changes course on graphic cigarette warnings | Reuters

    Back in January the Alabama Supreme Court issued a ruling that enabled individuals who took generic drugs to sue the brand-name manufacturer.  Not surprisingly, the brand-name companies are not happy:

    BIRMINGHAM, Alabama — Brand name makers of a drug used to treat acid reflux and other digestive problems today asked the Alabama Supreme Court to reconsider its January opinion that people who take generic equivalents of a drug can sue the brand name manufacturers.

    The U.S. Chamber of Commerce, the Business Council of Alabama, and four other groups also filed court briefs today supporting that request, saying the court’s earlier ruling could have far-sweeping consequences on healthcare, as well as other industries, in Alabama.

    Source: Brand-name drug makers ask Alabama Supreme Court to reconsider ruling that generic drug consumers can sue them | al.com

    Way back in 2010, I wrote a blog post about the “prison rape” of one of the companies that manufactured the drugs improperly administered by Dr. Dipak Desai.  Now another defendant is on the hook:

    Officials with Health Plan of Nevada knew in the late 1990s about Desai’s poor reputation after a doctor who was employed at one facility informed the company that Desai was cutting corners and compromising patient safety, Eglet said.

    Source: UnitedHealth Unit Liable for Doctor’s Errors, Lawyer Says – Bloomberg

    I’m actually much more open-minded about this defendant’s culpability.  If what the article says is true – the insurer had actual knowledge that the Dr. was a menace – it does raise serious questions as to why the insurer kept the doc on the approved list.  It will be interesting to see how the trial ends.