New Flu Drug Approved for First Time in 20 Years

By Health Day – Re-Blogged From Newsmax

For the first time in two decades, the U.S. Food and Drug Administration has approved a new type of antiviral flu drug.

The single oral dose of Xofluza (baloxavir marboxil) is for the treatment of uncomplicated flu in patients aged 12 and older who have had symptoms for no more than 48 hours.

When used within 48 hours of getting sick with the flu, antiviral drugs can reduce symptoms and duration of the illness, according to the FDA.

FDA OKs 1st Migraine Drug

By Associated Press – Re-Blogged From Newsmax Health

The FDA has approved the first drug designed to prevent chronic migraines. Aimovig is injected monthly just under the skin using a pen-like device and will cost $6,900 per year without insurance.

The Food and Drug Administration’s action clears the monthly shot for sale. Aimovig is the first in a new class of long-acting drugs for preventing migraines. Three other shots are expected to win approval by next year, and several pills for preventing migraines are being tested.

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Gene Therapy That Fixes Hereditary Blindness

By Patrick Caughill – Re-Blogged From Futurism

In Brief

An FDA advisory panel just unanimously approved a new gene therapy that can restore sight in patients with a rare genetic disorder. In clinical trials, more than 90 percent of patients saw improvement in eyesight.

Unanimous Vote

After some emotional testimony from doctors and patients, a Food and Drug Administration (FDA) advisory panel has voted unanimously to approve a gene therapy that improves hereditary blindness. The treatment will now progress to a final decision from the FDA and, if approved, will be the first gene therapy legally available in the United States for an inherited disorder. The FDA is under no obligation to follow the advisory board’s recommendation but usually does.

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Beyond Permissionless Innovation

By Veronique de Rugy – Re-Blogged From Reason.com

Exciting things happen outside the reach of regulators.

Paul McCarthy is the father of a boy born without fingers on one hand. A few years ago, McCarthy found that a $30,000 prosthesis—the only option then available—was not a perfect match for his 12-year-old son’s needs, so he went online to find a better, less pricey alternative. McCarthy’s search led to the assembly of an unlikely team: a South African woodworker, an American puppeteer, and another father in a similar situation. Thanks to the power of the Internet, the men were able to collaborate from thousands of miles apart to make an inexpensive but workable prosthetic appendage using 3D printers.

Such “permissionless” innovation, in which people with big ideas for how to make the world better act on them without first jumping through regulatory hoops, is remarkable. It’s also extremely fragile. The entire enterprise could crumble overnight with a stroke of a regulator’s pen, a change in an insurance company’s policy, or a lawsuit filed by entrenched manufacturing interests. It hasn’t so far in this case. But due to pressure from competitors that make traditional prosthetics, the company McCarthy and his partners created has already had to agree to define its product as a “training” prosthetic, thus opening the door to future regulatory limitations on its business model.

Consider how the Food and Drug Administration (FDA), in the name of safety at any cost, quashed the genomics company 23andMe by ordering it to stop marketing its cheap, at-home genetic testing kits. According to the agency, 23andMe should have obtained permission from regulators before selling its product to American consumers who were interested in learning more about their own personal genetic information.

Three Campaigns That May Save Your Life — If The Government FDA Permits It

Mini-Milestone – 100th Post

cropped-bob-shapiro.jpg   By Bob Shapiro

This is the 100th post to US-Issues.com. Most of the posts are original, plus about 10 reblogged posts. I’ve been active for about two months and have gained a small, but respectable size, following with about 1150 page views so far.

Comments have been received, although interestingly, most of these come through my personal (Bob Shapiro) Facebook page. So far, there have been no flames (Thanks!), and several back and forth comments.

Action Item

One feature that is included on the web site, is a listing of all the “Action Items” that I’ve called for, including a few US Constitutional Amendments, a few Congressional Rules changes, and a lot of new laws. These Action Items have dealt with reducing the size of our federal government:

  • Balance the Budget & Repay the National Debt
  • A Dollar Cap on Federal Spending
  • Eliminating Agencies like EPA, FDA, & the FED
  • Bill Max Length (50 pages) & Legislator MUST know what’s in the Bill in order to vote yes
  • Phase out various Entitlement Programs like Food Stamps, Medicare, ObamaCare, & Social Security
  • Stop Debasing the Dollar & Return to Silver and/or Gold Standard
  • Deregulate industries like Food, Drugs, Airline, & Energy
  • Stop Green Anti-Energy Programs like ending subsidies on Wind & Solar, prohibitions on fossil fuels, and CO2 CAGW Nonsense
  • Oversee & Correct Statistical Standards like CPI Manipulations
  • Stop Bailouts & Bail Ins allowing Too Big To Fail businesses to go into bankruptcy if they’re broke & incompetent

Issues

I’ve dealt with a broad range of issues, sticking mostly to our Tag Line, “Political Issues of Economic Importance.” I’ll try to keep giving you more good, thoughtful pieces that you’ll be happy to read.

Thank you for reading my Blog!

Sight, Sound, & Movement – Free Market Solutions

cropped-bob-shapiro.jpg   By Bob Shapiro

I’ve been very upbeat on the power of creativity & innovation, within the Free Market System, to improve the lives of Americans greatly, an even people world-wide. And I tend to be highly critical of regulatory agencies, such as the FDA, which hold back creativity & innovation and often exist not to regulate their industries but to extend protective benefits to them.

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