| Details on the 21st Century Cures Act Originally the bill was HR 6 and passed the house on July 10, 2015. Many of the provisions of HR 6 were broken up into small bills and ultimately the bill was reworked. The new bill removed some of what was in HR 6 and added more. It was amended onto HR 34 which it titled, "Tsunami Warning, Education and Research." It is expected that the bill will move on to the US Senate next week.
Some of the problems with the 21st Century Cures Act -There are many problems with this bill that specifically hurt the disability and special needs community. Provisions for home care providers create big brother mechanisms in (IHSS) In Home Supportive Services with the creation of the electronic visit verification system (5) In this subsection: "(A) The term 'electronic visit verification system' means, with respect to personal care services or home health care services, a system under which visits conducted as part of such services are electronically verified with respect to— "(i) the type of service performed; "(ii) the individual receiving the service; "(iii) the date of the service; "(iv) the location of service delivery; "(v) the individual providing the service; and "(vi) the time the service begins and ends. Makes it easier for electric shock "therapy" fast tracked as a cure for autism as well and other conditions ..."lobbyists are pushing for a Senate vote this coming week on a bill called "The 21st Century Cures Act" – or HR 34 in its newly "amended" form. The law calls for skipping scientifically sound safety testing of new medical devices in the guise of helping desperate cases, but it would result in harmful and potentially deadly new gadgets being rolled out for use on the general population. Fast tracking drugs and products to the market as the 21st Century Cures Act allows hurts rather than helps According to the HealthAffairs org article The Current 21st Century Cures Legislation is Still a Bad Deal for Patients, "Fast tracking drugs and products to the market as the 21st Century Cures Act allows hurts rather than helps ..."we believe the bill's potential benefits and modestly enhanced funding for scientific advancement are far outweighed by the increased risk of patient harm, and added pressure on the FDA to rush new products to market without adequate evidence. The current 21st Century Cures Act would not drive innovation. Instead, it represents a poor deal for patients." "(Sec. 2022) The sponsor of a drug for a serious condition may request that the FDA agree to an accelerated approval development plan. The plan must include the design of the drug study." Enrollment in clinical trials for drugs and devices as long as there is "minimal risk" to the patient and practitioner and as long as there are "safeguards" and Pharmaceutical funding influencing research without giving patients informed consent We use clinical trials not only to study the efficacy of drugs and devices, but also to determine their safety profiles. Under the 21st Century Act, no clinical trial can proceed unless the safety profiles are known. The effect of this act is to leave "safety" to guesswork and rationalization, and to allow the medical establishment to assess harm in drugs and devices in a manner in which (1) the patients are not informed that they are in a clinical trial, and (2) they have no right to say "No" to being part of an experiment. If they are harmed during the trial, they cannot know that they should sue because any ill effect of the experimental drug or device cannot be traced to the experiment. This allows the medical establishment to experiment on the population with impunity. The act does not specify "minimal risk". The act stipulates that as long as no more the 8,000 people are being studied, uninformed consent is okay. Pharmaceutical corporations have thousands of drugs and devices waiting to be tested. How many people's lives will end due to unsafe treatments? We already know that these pharmaceutical corporations cannot be trusted with safety trials (see Vioxx). "(Sec. 2222) "Valid scientific evidence" is defined for purposes of the FDA determining the effectiveness of a medical device without clinical investigations" "(Sec. 2263) Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards." Removes requirement that manufacturers of medical products report payments to physicians for certain "educational" activities "(Sec. 3041) Part A (General Provisions) of title XI of the SSAct is amended to remove the requirement that manufacturers of medical products report payments to physicians for certain educational activities." Likelihood of prescription drug prices increasing and becoming less accessible to lower income patients "(Sec. 4002) Generic drugs authorized by the brand name drug manufacturer are excluded from the calculation of average manufacturer price when determining rebates under Medicaid." CDC surveillance of neurological diseases "(Sec. 1122) The Centers for Disease Control and Prevention (CDC) must expand surveillance of neurological diseases." 21st Century Cures Act in the media "David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards.
"Kaiser Health News reviewed the lobbying records filed by the Pharmaceutical Researchers and Manufacturers of America, the trade group representing drug makers, and found the industry group spend up to $24.7 million lobbying on the bill. (On some of the lobbyists' disclosure forms, multiple healthcare laws are listed, and it was not clear how the industry's lobbyists divided their time.) The mega-drug maker AbbVie — which manufacturers Humira, one of the most lucrative pharmaceuticals marketed for multiple uses — spent up to $7.7 million. The U.S. Chamber of Commerce spent up to $136.5 million. Senators speak out about the 21st Century Cures Act US Senator Elizabeth Warren asked, "Does the Senate work for Big Pharma or the American People?" in response to the bill. US Senator Bernie Sanders said, "This is a bad bill, which should not be passed in it's current form...it's time for Congress to stand up to the world's biggest pharmaceutical companies, not give them more handouts." Further articles and commentary House lawmakers passed the biggest health reform bill since the Affordable Care Act Please forward and share this CALL TO ACTION with your friends, your families, and the families you serve! Time is of the essence, and it's not on our side! | 
