Tag Archives: FDA

Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush

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http://healthaffairs.org/blog/2016/07/11/congress-shouldnt-pass-the-21st-century-cures-act-in-a-summer-rush/

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On Saturday June 25, six former FDA commissioners from Democratic and Republican administrations suggested at the Aspen Ideas Festival that Congress make the agency independent of the Department of Health and Human Services — similar to the Securities Exchange Commission, for example. With regulatory purview over products that represent a quarter of the U.S. economy, the group said the FDA is harmed by an unstable federal budget process and persistent political meddling. The group said they would issue a white paper on their proposal for the next administration. That’s another reason why Congress should postpone consideration of these bills until 2017.

An inside look at the world of drug presentations

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http://www.scpr.org/news/2016/07/01/62183/an-inside-look-at-the-world-of-drug-presentations/

Critics say the system is flawed because it’s paid for by drug makers with a financial stake in the outcome.

Presentations sponsored by pharmaceutical companies only focus on one drug and do not include all the options available, including generics, says R. Adams Dudley, Director of the Center for Healthcare Value at the University of California San Francisco.

“They’re going to emphasize the education aspect of it but they wouldn’t pay for it if it did not lead to sales,” he says.

 

Hundreds of companies in the U.S. are selling unproven stem cell treatments, study says

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http://www.latimes.com/science/sciencenow/la-sci-sn-unapproved-stem-cell-treatments-20160630-snap-story.html?utm_campaign=CHL%3A+Daily+Edition&utm_source=hs_email&utm_medium=email&utm_content=31233055&_hsenc=p2ANqtz-8svW-TMtAyJFwmvKzoDjfSTTtMgsgUedtyaYE4wt_o_C_TfMcpXDmfnnRYA2UDkrCnoabntZCBkmKkB9YYl0RLteiYnA&_hsmi=31233055

Self-described stem cell clinics in the U.S.

From coast to coast, at least 351 businesses at 570 locations are marketing stem cell therapies that have not been fully vetted by medical researchers or blessed by the U.S. Food and Drug Administration, according to a study published Thursday in the journal Cell Stem Cell.

Paul Knoepfler, a bona fide stem cell researcher at UC Davis with a doctorate in molecular pathology, and Leigh Turner, a bioethicist at the University of Minnesota who studies the ramifications of medical tourism, scoured the Internet to find companies advertising all sorts of stem cell treatments directly to patients and their families. They used nearly 100 search terms to identify as many websites as they possibly could — and turned up a lot more than they thought they would.

CardioBrief: FDA Asks Voluntary Sodium Cuts by Food Industry

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http://www.medpagetoday.com/Cardiology/CardioBrief/58258

SALT

The FDA wants to lower sodium consumption in the general population by targeting food manufacturers and restaurants. According to the FDA, most of the sodium in the U.S. diet comes from processed and prepared foods. The long-term goal is to gradually lower sodium intake from the average of about 3,400 mg/day to 2,300 mg/day. In the short-term, the FDA aims to reduce sodium intake to 3,000 mg/day.

Paying for future success in gene therapy

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http://science.sciencemag.org/content/352/6289/1059.full

Gene Therapy

DEVELOPMENT OF GENE THERAPY. Forty-four years have elapsed since an article appeared in Science on the possible therapeutic benefits of gene therapy (1). The early history was marked by poor trial design and a need for greater attention to basic aspects of viral gene transfer and disease biology (2). After some tragic setbacks and years of research to redesign existing vectors and identify safer ones, several trials have recently delivered promising results in regard to both safety and efficacy in several immunodeficiency disorders (3, 4), hemophilia B (5), a form of congenital blindness (6, 7), beta-thalassemia (8), and metachromatic leukodystrophy (9). We presume that gene therapy for at least one disorder currently in clinical trials will be established as safe and efficacious and that will lead to U.S. Food and Drug Administration (FDA) approval in the next 3 years.

Inventing a Machine That Spits Out Drugs in a Whole New Way

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http://www.healthleadersmedia.com/technology/inventing-machine-spits-out-drugs-whole-new-way?spMailingID=8976156&spUserID=MTMyMzQyMDQxMTkyS0&spJobID=922552058&spReportId=OTIyNTUyMDU4S0

The Defense Department is funding a device that produces 1,000 pills in 24 hours and raises the possibility that hospitals and pharmacies could make their own pills as needed.

Bone cement company accused of experimenting on humans

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https://www.washingtonpost.com/national/health-science/bone-cement-company-accused-of-experimenting-on-humans/2016/05/21/db528f94-1f97-11e6-82c2-a7dcb313287d_story.html

In this Aug. 16, 2007, photo provided by Cynthia Wilson, Reba Golden stands outside Harborview Medical Center in Seattle. Golden died on the operating table there the next day during what should have been a routine spinal surgery. Like several other spinal surgery patients before her, Golden died after her surgeon injected bone cement into her spine and some of the material leaked into her blood stream, causing massive clotting. Also like the other patients, Golden was never told that the bone cement was not approved by the Food and Drug Administration.

Is High Prescription Drug Spending Becoming Our New Normal?

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http://healthaffairs.org/blog/2016/05/17/is-high-prescription-drug-spending-becoming-our-new-normal/

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Drug Regulation and Pricing — Can Regulators Influence Affordability?

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http://www.nejm.org/doi/full/10.1056/NEJMp1601294?utm_campaign=KHN%3A+Daily+Health+Policy+Report&utm_source=hs_email&utm_medium=email&utm_content=29514168&_hsenc=p2ANqtz-_mhuZY8I1CwE2JaU7KXf7klesY9p7YngvovjjsHKAbNVfnE2nViv1V8f1h8S0PR5h41XLpae3XGq5fFQ5NnvEuAJ0UEw&_hsmi=29514168&

High Drug Costs

Public debate in the 1990s over drugs’ clinical toxicity has given way to concerns about their financial toxicity. Although drug regulators aren’t supposed to be concerned with pricing, they’ve been drawn into an acrimonious debate over the cost of medicines.