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Protecting Consumer Safety Must Remain Top Priority in Drug Regulation
A balancing act: Making sure drugs are safe before going to market without hampering innovation.
April 23, 2011 /Mens Interest PR News/ -- Protecting Consumer Safety Must Remain Top Priority in Drug Regulation
In recent years, there has been extensive debate concerning how much government oversight there should be over new drugs and medical devices. Some observers - principally those in the pharmaceutical and medical industries - argue that the current FDA regulatory scheme hampers the ability to bring new drugs to market, which in turn hurts patients who would benefit from their use.
Others, however, point out that government oversight is necessary to ensure that these drugs are sufficiently tested for potentially dangerous side effects and other safety concerns before being released on the market. Proponents of regulation also argue that the recent increase in recalls of dangerous drugs suggests the need to improve regulation, rather than reduce it.
Pre-Marketing Testing, Tort System Blamed for Stalling Medical Innovation
A recent op-ed piece in Forbes magazine was written by an author soundly in the first camp. In Are We Thwarting Medical Innovation?, the author said that too much government regulation over new medications is bad for everyone and argued that several important changes need to be made, including scaling back FDA pre-market testing requirements and passing tort reform to eliminate punitive damages against drug manufacturers.
While acknowledging the need for at least some government oversight to provide a measure of consumer protection from potentially dangerous drugs, the author expressed a fondness for the days when there was no regulation over the drug industry and market forces were allowed to dictate which drugs were successful and which were not. He writes:
-"Before FDA control, which took hold in the years after the Pure Food and Drug Act of 1906, the market was largely without barriers. A pharmacist might bring forth Bromo-Seltzer, or Noxzema, or Coca-Cola, or little liver pills or laudanum. Market forces would then determine if the product had value. Only tort liability acted as a check on the manufacturer, and, interestingly, there were few lawsuits."
The author said that the number of new medications making it to the market in the last 15 years has been reduced by nearly 50 percent, with approximately only 20 new drugs gaining approval for release each year. He indicated several reasons for this decline, including the rigorous pre-market testing requirements drug manufacturers must perform, which adds significant costs to the process.
The author also blamed the legal system for bogging down the process of bringing new drugs to market, saying that innovation has been hurt by the increase in product liability suits, including class actions, punitive damages, and the growing trend of imposing strict liability for any harm caused regardless of other facts that work against the injured party, such as known risks inherent in taking many types of drugs.
Rise in Dangerous Drug Recalls Points to Need for Increased Regulation
While the author of the Forbes piece spent considerable time discussing all the ways the pharmaceutical industry is harmed by regulation, he spent no time discussing how consumers have been harmed by dangerous drugs.
The bottom line is that even though everyone recognizes the importance of bringing new drugs and medical devices to market as quickly as possible, it cannot be done in a manner that puts public safety at risk. Side effects from prescription medications are responsible for killing an estimated 100,000 people each year in the U.S. - which does not include those who die as a result of accidental overdoses, prescription and dosage errors, and other medication mistakes.
Given the rise in the number of recalls and imposition of black box warnings on both recently released drugs and those that have been on the market for some time, it is obvious that a decrease in FDA safety regulations is not in the public's best interest and could only result in greater harm than good. Here is just a sampling of some of the medications and devices that have been recalled by the FDA in recent years:
-Darvocet and Darvon (painkillers)
-Avandia (diabetes treatment)
-Meridia (weight loss drug)
-Vioxx (arthritis pain killer)
-Medical devices like the Depuy Hip Replacement and Guidant Defibrillators
-Reglan (black box warning added to the acid reflux treatment)
In fact, the growing public concern over the increase in drug recalls and the lack of oversight over newly-released medications led the FDA to begin publically publishing post-market drug safety information on its website last summer. The summaries that are posted include information on new safety risks that have been reported, including side effects that were not present during testing or that have increased in frequency since testing.
Changing legal liability laws also will not improve biomedical innovation, but instead will remove the incentive for drug manufacturers to take care in producing their products. It is unfair to punish those who have been harmed or lost a loved one to a defective medical device or dangerous drug by limiting their available legal remedies. Tort system reform will accomplish mainly one end - insulating big drug companies from lawsuits at the expense of individuals who were prescribed dangerous drugs.
Conclusion
The law plays an important role in protecting the public from dangerous drugs and defective products. While it is important that federal and state regulation does not become so burdensome as to cripple innovation in the medical industry, the law of product liability should not be stripped of its ability to compensate injured consumers.
Article provided by Scott H. Palmer, P.C.
Visit us at www.scottpalmerpilawyer.com
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