Friday, July 5, 2019 - The US Food and Drug Administration has lifted their Risk Evaluation Management (REM) requirements from anti - HIV drug Truvada. The FDA will often go the extra mile and require that physicians and patients complete a questionnaire to ensure both parties are aware of the relative risks and rewards that a drug therapy presents. Another reason for the REM is that often a certain drug may be so effective that it is also highly toxic. The FDA requires that most drugs like Truvada carry the REM requirements for seven years, an adequate period of time for doctors to become familiar with a drug's risk profile. Gilead, the maker of Truvada, has agreed to donate 2.4 million bottles of the anti-HIV drug annually to the CDC for distribution to HIV positive patients throughout the United States. The drug's giveaway will transition to the company's other drug Descovy through the year 2030 provided the drug receives FDA approval.
The FDA describes the Truvada Risk Evaluation Management as follows: "A REMS goes beyond a drug's written prescribing information and can include a Medication Guide, communication plan, and other elements to ensure the safe use of a drug. A REMS is required to mitigate a serious risk listed in the product label." REMs usually include guidance on screening patients and monitoring them for specific symptoms on a monthly basis. Truvada has been reported to cause bone density loss that can lead to fractures as well as kidney and renal failure. Truvada lawsuits attorney believe persons and family members of persons who developed acute or chronic kidney problems and suffered from broken or brittle bones while taking Truvada may be eligible for real compensation for the pain, suffering, medical expenses, lost income and other damages suffered, by filing a claim against Gilead.
Transitioning from one drug that is going off patent to another made by the same company is nothing new to the pharmaceutical industry when a company seeks to maintain its hard-earned market share. What is eye-opening, however, is when a company develops a monopoly for the prevention of one of the world's deadliest diseases and double, then double again, the price of the drug, a price increase so absurd that virtually no one who is poor or uninsured can get the drug. Gilead charges around $2000 per month for Truvada up from around $1300 just a few years ago. The company is being accused of cutting an under the table quid pro quo deal with the Trump administration whereby Truvada agrees to supply the drug for free in exchange for the FDA approving Descovy and the CDC transitioning to it. Such a move is viewed as anti-competitive and assures that only a fraction of those who really need the drug can receive it and the remainder of people must continue to pay top dollar for it. Congress also argues that the US taxpayer deserves better since Truvada's discovery and development was made by Gilead scientists using taxpayer funding therefor Truvada's patient belongs to the people. Gilead CEO Daniel O'Day contends that such a price increase is necessary if companies are to be incentivized to assume the risks essential to the development of new drugs. Congress argues that it was the taxpayer who took the risk.
OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The firm has represented thousands of persons in these and other products liability litigation, including DePuy hip replacement systems, which settled for $2.5 billion and Pradaxa internal bleeding, which settled for $650 million. The Onder Law Firm won over $300 million in four talcum powder ovarian cancer lawsuits in St. Louis to date and other law firms throughout the nation often seek its experience and expertise on complex litigation.