Vaccine Maker Immunity QuestionedFeb 23, 2009 | Parker Waichman LLP
security , according to a report in today’s Wall Street Journal. The pharmaceutical industry disagrees.
SmartBrief pointed that a relatively recent ruling found that families of autistic children are not eligible for compensation under the program, which has many wondering to whom the program offers the most benefits.
According to FiercePharma, vaccinations have become a huge boon for industry, pointing out that the Program, which was developed in 1986, was meant for the development of vaccines to prevent childhood diseases and to ameliorate the dearth of companies willing to remain in a vaccine business heavy with lawsuits and minimal profits. The Wall Street Journal (WSJ) noted that the vaccines worked and significantly minimized a wide variety of childhood diseases.
Because vaccine sales have increased and represent a business expected to garner over $21 billion in profits over the next couple of years, critics feel the program is no longer needed, said the Journal. As the Journal pointed out, the program prompted the creation of a special vaccines court—known as the Office of Special Masters at the U.S. Court of Federal Claims—in 1986 and limited damages to only $250,000 in the worst of all scenarios: Death cases. That's little recompense for patients and families of patients who believe vaccines have caused severe, life-long, and crippling harm.
There especially seems no hope for injury claims, especially in light of the recent ruling that found no link between childhood vaccinations and autism. Of note, said the WSJ, had the Vaccine Court found in favor of the families, payment would not have been generated by the vaccine companies. Instead, the government would have used monies from a tax assessed on inoculations to cover the fees.
Regarding the special court, Lars Noah, a specialist in medical technology at the University of Florida's law school, told the WSJ, "When you've got a monopoly and can dictate price in a way that you couldn't before, I'm not sure you need the liability protection." Of course, the pharmaceutical industry disagrees, claiming that it needs the protection to continue with clinical trials.
In addition to the benefit of the special program, the vaccine court, and the financial cap, vaccine makers have a decided benefit over drug manufacturers since vaccines cannot be made into generics, said the WSJ.
Barbara Loe Fisher, co-founder of a nonprofit parents' group called the National Vaccine Information Center, a fierce voice against making Merck’s Gardasil vaccines mandatory, and one of those who worked on the original law, says high-priced, emerging vaccines, such as Gardasil, which are not critical to pandemic prevention, do not work in concert with the original law.