Supremes Say You Can’t Sue Generic Drug Makers But FDA May Change That
On June 24, 2-13 the U.S. Supreme Court, in a 5-4 decision ruled that generic drug manufacturers are not liable for the design of the drugs. That means if their drugs make you sick you can’t sue them. One could easily believe that’s like saying that a Jet passenger airliner that was approved as safe by the FAA in the 1960’s is immune from all law suits even if in ensuing years it was proven that stress fractures caused engines to fall off and planes to crash killing hundreds— but I am getting ahead of myself and besides a ruling by the Food and Drug Administration (FDA) could change all that. Confused? Read on.
Before we get to the decision it is important to understand just what a generic drug is and how it becomes one. When a new, FDA-approved drug goes on the market, it may have patent or other protection that enables the manufacturer to sell the drug exclusively for a period of time. When those protections expire other companies can make it in generic form but the FDA must approve the generic drug before it can be marketed.
For a generic drug to be approved by FDA, its manufacturer must show that it is “equivalent” to the innovator drug (brand name). This means that to gain FDA approval, a generic drug must:
- Contain the same active ingredients as the innovator drug. Active ingredients make the drug effective against the disease or condition it is treating.
- Come in the same dosage form. If the brand name is a capsule, the generic should be a capsule, too.
- Be administered the same way. If the brand name is taken orally, the generic should be taken orally, too.
- Be identical in strength
- Have the same conditions of use
- Be bioequivalent (an equal rate and extent of drug absorbed in the bloodstream)
- Meet the same standards for identity, strength, purity and quality
- Be manufactured under the same standards that FDA requires for the manufacture of innovator products
As I researched this story I found that the FDA encourages people to notify them of side effects or reactions to these generic drugs. I found little or no information that suggested how or even if the FDA acted upon public complaints so conceivably there could be a great number of complaints about an adverse effect but if the FDA takes no formal action the Generic manufacturer has no obligation to issue any warnings or reformulate the drug…which leads us to today’s supreme court ruling.
In a dissenting opinion, Justice Sonia Sotomayor said a decision by the F.D.A. to approve a drug should not absolve a company of its responsibility to sell a safe product.
“Manufacturers regularly take drugs off the market when evidence emerges about a drug’s risks, particularly when safer drugs that provide the same therapeutic benefits are available,” she wrote in her dissent, which was joined by Justice Ruth Bader Ginsburg. Justice Stephen G. Breyer wrote a separate dissent, which was joined by Justice Elena Kagan.
Some have called on Congress and the F.D.A. to make generic drug companies more accountable by permitting them to change their warning labels when they become aware of a safety risk. Brand-name companies can already do so. Such a change would, presumably, allow the generic manufacturers to be sued again.
Generic drug makers now have a responsibility to mirror the safety label of the brand-name company and to alert the F.D.A. whenever they learn of an adverse event related to their products. It is then up to the agency to decide whether to change the label.
Critics have said the current system works too slowly, and does not account for situations when problems arise with a drug after the brand-name manufacturer has left the market.
The consumer advocacy group Public Citizen released a report Monday that found 11 instances over the last five years in which serious safety warnings were added to the labels of drugs for which there were no longer any brand-name versions on the market.
This situation “poses a threat to the safety of prescription drugs, creating unnecessary risks to patients,” Dr. Michael Carome, director of the Health Research Group at Public Citizen, said in a statement Monday.
But now a new twist.
The June action by the supreme court slashed the right of individuals to sue for damages when injured by generic drug makers…..but an action by the Food and Drug Administration might change that. The Times Katie Thomas reported this good news yesterday:
“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”
Dozens of lawsuits against generic drug manufacturers have been dismissed since 2011, when the Supreme Court ruled that because the generic companies must, by law, use the same label warnings as their brand name counterparts they cannot be sued for failing to alert patients about the risks of taking their drugs. Last month, the Supreme Court ruled — on similar grounds — that patients also may not sue generic drug makers by claiming that the drug was defectively designed.
Have we heard the last of this issue? No way. The pharmaceutical industry has billions to spend to defend itself and to launch massive PR campaigns. They’ve done it in the past and you can bet the will do it again. Stay tuned.
Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s nearly 3,000 member Organ Transplant Initiative and the author of most of these donation/transplantation blogs.
You may comment in the space provided or email your thoughts to me at firstname.lastname@example.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.
Please view our new music video “Dawn Anita The Gift of Life” on YouTube https://www.youtube.com/watch?v=eYFFJoHJwHs. This video is free to anyone who wants to use it and no permission is needed.
If you want to spread the word personally about organ donation, we have another PowerPoint slide show for your use free and without permission. Just go to http://www.organti.org and click on “Life Pass It On” on the left side of the screen and then just follow the directions. This is NOT a stand-alone show; it needs a presenter but is professionally produced and factually sound. If you decide to use the show I will send you a free copy of my e-book, “How to Get a Standing “O” that will help you with presentation skills. Just write to email@example.com and usually you will get a copy the same day.
Also…there is more information on this blog site about other donation/transplantation issues. Additionally we would love to have you join our Facebook group, Organ Transplant Initiative The more members we get the greater our clout with decision makers.
Puede comentar en el espacio proporcionado o por correo electrónico sus pensamientos a mí en firstname.lastname@example.org. Y – por favor, difundir la palabra acerca de la necesidad inmediata de más donantes de órganos. No hay nada que puedas hacer lo que es de mayor importancia. Si usted convence a una persona de ser donante de órganos y tejidos puede salvar o afectar positivamente a más de 60 vidas. Algunas de esas vidas pueden ser personas que conoces y amas.
Por favor, consulte nuestro nuevo video musical “Dawn Anita The Gift of Life” en https://www.youtube.com/watch?v=eYFFJoHJwHs YouTube. Este video es libre para cualquier persona que quiera usarlo y no se necesita permiso.
Si quieres correr la voz acerca de la donación de órganos personalmente, tenemos otra presentación de PowerPoint para su uso libre y sin permiso. Sólo tienes que ir a http://www.organti.org y haga clic en “Life Pass It On” en el lado izquierdo de la pantalla y luego sólo tienes que seguir las instrucciones. Esto no es un espectáculo independiente, sino que necesita un presentador pero es profesionalmente producida y sonido hechos. Si usted decide usar el programa le enviaré una copia gratuita de mi libro electrónico, “Cómo obtener un pie” O “que le ayudará con habilidades de presentación. Sólo tiene que escribir a email@example.com y por lo general usted recibirá una copia del mismo día.
Además … hay más información sobre este sitio de blogs sobre otros donación / trasplante temas. Además nos encantaría que te unas a nuestro grupo de Facebook, la Iniciativa de Trasplante de Órganos Cuantos más miembros que obtenemos mayor será nuestra influencia con los tomadores de decisiones.