There is a similarity between how you can get the generic prescription drugs that work as well as your name brand drug & the military’s policy on alternative lifestyles. “Don’t ask, Don’t tell.”
What this means is pharmacists, through contracts beneficial to Big Pharma, have agreed not to offer to clients who do not directly ask that a cheaper, generic version is available of their medicine, as a medical malpractice lawyer knows all too well. Under Obamacare, it was no longer mandatory that the prescription specifically state that it was allowed to substitute a generic drug.
Another strategy Big Pharma uses to drive up the cost of prescriptions is to limit release of name brand drugs in order to prevent access to samples. When a generic manufacturer is not able to buy drug samples, it is impossible to do the careful testing that’s needed to ask the Food and Drug Administration (FDA) to approve the medication. FDA Commissioner Scott Gottlieb has called these tactics, “unfair and exploitative,” as well as “in direct conflict to our broader public health goals.”
In many cases this puts patients at risk who cannot afford greatly inflated prices for life-saving treatment. Cancer patient David Mitchell testified before Congress about one company’s efforts to deny a generic company’s access to samples of Revlimid, a cancer treatment he believes saved his life. Access to samples of the drug has been at issue since 2009. If it were not for this ongoing abuse of the FDA’s safety programs, a generic alternative could be available to David and other patients as early as next year.
Because there is no generic alternative, the cost of Revlimid has remained artificially high and has actually risen fourteen times since this abuse began, from $9,853 in 2010 to its current price of $18,546 for a 28-count bottle. This is just one example out of more than 150 complaints that the FDA has received from generic manufacturers.
To end these anti-competitive tactics, a bipartisan coalition of lawmakers — including Republican Sens. Mike Lee (Utah), Ted Cruz (Texas), Rand Paul (Ky.), and Democratic Sens. Amy Klobuchar (Minn.), Dianne Feinstein (Calif.), and Dick Durbin (Ill.), have joined us to introduce the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. This bill is supported by a broad and politically diverse coalition of 68 organizations representing hospitals, physicians, patients, employers, and unions. AARP, Families USA, FreedomWorks, and Heritage, to name just a few, have endorsed this common-sense legislation. The public also agrees: Recent polls show that 84 percent of Americans support the CREATES Act.
The act is not a drastic measure, but allows the generic development process to proceed as intended by Congress under the Hatch-Waxman Act. Companies making brand-name pharmaceuticals need only to negotiate in good faith and provide the samples for testing on market terms to avoid a lawsuit.
Thanks to our friends and contributors from The Law Offices of Konrad Sherinian for their insight into generic drugs and medical malpractice.