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OpenMarket: Health Care

  • FDA Needs to Act on Internet and Social Media Policy

    December 16, 2011
    Way back in September 2009, the Food and Drug Administration announced that it would begin using the social media site Twitter to share news and other information about drug safety and regulation. "Messages on Twitter provide consumers, healthcare professionals, the pharmaceutical industry, and others with timely information on new drug approvals, safety alerts, compliance actions, and consumer information," the announcement said. It was curious that FDA mentioned the pharmaceutical industry. You see, drug and device companies have been feeling their way around the Internet and other new media, including Twitter, for several years without substantive guidance from the FDA. That's important because, under the Food, Drug and Cosmetic Act, there's a lot that's not permitted, but nobody's quite sure what is and what isn't. And if the...
  • Over-The-Counter Plan B? What Would Jed Bartlet Do?

    December 8, 2011
    Back in March 2009, President Obama issued a memorandum on scientific integrity to the heads of executive branch agencies and departments. It announced that “[s]cience and the scientific process must inform and guide decisions of [his] Administration on a wide range of issues.” And in a statement to the press, Obama insisted that “Our government has forced what I believe is a false choice between sound science and moral values.” Previous administrations (and one in particular -- nudge nudge, wink wink … Know what I mean?) had let politics interfere with what should have been purely...
  • Good News/Bad News on Compensating Bone Marrow Donors

    December 7, 2011
    By now, there's been plenty of news highlighting last week's decision by the Ninth Circuit Court of Appeals that the National Organ Transplant Act of 1984 (NOTA) does not forbid compensation for the majority of bone marrow donors. That's great news for patients needing marrow transplants. And the non-profit Institute for Justice deserves a tremendous amount of applause for arguing the case. Unfortunately, the decision is far narrower in scope than it has been portrayed by some news outlets. And, although there is plenty here to celebrate, it neither "...
  • Reforming Medical Malpractice Law: Interesting Discussion about Damage Limits in Malpractice Cases

    December 7, 2011
    Point of Law has an interesting debate over whether medical-malpractice noneconomic damage caps hurt consumers, between Ted Frank and Shirley Svorny. As Frank notes, "medical malpractice awards are" often "haphazard," failing to distinguish between negligent and non-negligent physicians (jurors are, after all, not experts in medicine, and may be unable to understand scientific concepts that undergird some malpractice lawsuits)....
  • Legalizing Kidney Sales Would Save Thousands of Lives, Save Taxpayers a Bundle

    December 6, 2011
    Kidney sales should be legal, explains kidney donor Alexander Berger in The New York Times. Berger is a research analyst for GiveWell, a nonprofit that helps charitable donors decide where to give. As Berger notes, allowing kidney donors to be compensated would save countless lives by providing people with an incentive to donate their kidneys. Right now, you have to be unusually altruistic to donate a kidney, since you have to spend several days in the hospital to donate one, take off a lot of time from work, and run a tiny, tiny risk of death from surgery. Most people just aren't that altruistic. Allowing kidney sales would also help the poor, who currently often...
  • Obamacare Attacks Your Flex Account -- Minimize Damage in 2013 by Doubling Up for 2012

    November 21, 2011
    Hey Joe and Jane Citizen, concerned about the future of your country and your family. Please step away for five minutes from the nonstop TV coverage of the supercommittee. You are being told that if the House-Senate committee, created as a compromise in the debt ceiling fight, doesn't reach a "solution" by Thanksgiving, there will be dire consequences as government spending  has to be "sequestered" from the budget in 2013. But the real dire consequences you should be worried about in 2013 is the permanent sequestration of your flexible spending account due to the stealth tax hikes of Obamacare. Back in 2010 when she was Speaker of the House, Rep. Nancy Pelosi said Congress had to pass the health care bill into law, so the public could know what's in it. And it won't be until the beginning of 2013 that most of the public will know that one of the things in the bill was a cap on flex...
  • Sen. Hagan Bill Would Expand Accelerated Drug Approval

    November 17, 2011
    According to Bloomberg News, North Carolina Democratic Senator Kay Hagan is set to introduce a bill that would create new "progressive" and "exceptional" approval processes for new drugs to treat unmet needs. These would be similar to the FDA's existing "accelerated approval" process, open primarily to AIDS and cancer drugs, which permits the agency to grant a conditional approval once intermediate clinical trials demonstrate improvement in a so-called "surrogate end-point" such as tumor shrinkage. Once granted accelerated approval, these drugs must still complete more rigorous Phase III...
  • Supreme Court Grants Review in Case Challenging Obamacare as Unconstitutional

    November 14, 2011
    The Supreme Court today granted certiorari in the Obamacare cases brought by 26 states and the National Federation of Independent Business. The court allotted 5 1/2 hours for arguments in the case. That's many times the length of a typical Supreme Court argument, and probably more time than was devoted to any other case in the last century, says Supreme Court commentator Lyle Denniston. The U.S. Court of Appeals for the Eleventh Circuit had declared the health care law's individual mandate (requirement that individuals buy health insurance) unconstitutional as beyond Congress's power under the Interstate Commerce Clause (Article 1, Section 8 of the Constitution). But it declined to strike down the rest of Obamacare, including provisions that even the government conceded were intertwined with,...
  • Obama Administration Contributes to Life-Threatening Drug Shortages Even as it Decries Them

    November 4, 2011
    In a recent column, Michelle Malkin explained how Obamacare price controls, FDA and DEA rules, and Obama administration policies have contributed to shortages of crucial life-saving drugs, relying on (and linking to) sources as varied as ABC News, The Wall Street Journal, and the New England Journal of Medicine. Earlier, law professor Richard Epstein, a leading authority on property rights, explained how Medicare regulations and price controls are helping spawn shortages of cancer drugs needed by chemotherapy patients and others. As biotech expert Greg Conko has noted, the FDA contributes to critical drug shortages because it "...
  • Biotechnology's 29th Anniversary!

    October 28, 2011
    Twenty-nine years ago tomorrow, the U.S. Food and Drug Administration approved Eli Lilly’s and Genentech’s Humulin, making it the first ever fully approved product of recombinant DNA, or what we now call modern molecular biotechnology. Humulin was the first biosynthetic human insulin, produced by splicing the human gene that codes for insulin production into a harmless microbe. Previously, diabetics who needed supplemental insulin used bovine or porcine insulin that was purified from the pancreases of cows and pigs. They worked reasonably well, but were not perfect analogues of human insulin. With the introduction of Humulin they could now take actual human insulin, which...


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