Tag: "FDA"

Jeb Bush Health Reform: Innovation and Patient-Centered Care

Bush2(A version of this Health Alert was published by The Hill.)

By avoiding sound bites and respecting voters’ ability to understand issues, Governor Jeb Bush’s health-reform proposal demonstrates strong leadership. Repeal and replace Obamacare? Sure, Bush is for that, but no Republican politician should win points simply by regurgitating what many citizens fear has become little more than a slogan.

Hillary Clinton Wrong on Prescription Drugs

Hillary(A version of this Health Alert was published by the Washington Examiner.)

With perfect timing, Hillary Clinton’s presidential campaign announced a proposal to impose federal price controls on prescription drugs the day after Turing Pharmaceuticals declared it was raising the price of Daraprim, a medicine to combat the “toxoplasmosis” parasite, from $13.50 to $750 per pill.

Jeb Bush’s Health Plan

BushJeb Bush’s health plan is out – and it is very good. Bush leads with fundamental reform of the Food and Drug Administration. “It should not cost $1.2 billion to $2.6 billion nor take 12 to 15 years to advance a medicine from discovery to patients, but that is the case under the Food and Drug Administration’s current regulatory mess.”

In recent weeks, we’ve read stories about drugs that have been around for decades, for which prices have been hiked sky-high. These price hikes are carried out by executives taking advantage of obscure FDA rules that impede competition.

FDA Driving Drug Prices into Stratosphere

BloombergBusiness has another story of a jaw-dropping price hike for a very old medicine. In this case,

Colchicine, a gout remedy so old that the ancient Greeks knew about its effects, used to cost about 25 cents per pill in the U.S. Then in 2010 its price suddenly jumped 2,000 percent.

How did this happen? Colchicine is one of a small number of drugs that were marketed before 1938. That year, the Food, Drugs, & Cosmetics Act was passed to require new drugs to be approved for “safety” as well as be “pure” (that is, not adulterated or misbranded as required since 1906).

Martin Shkreli A Creature of FDA Regulation, Not Pharma Industry’s Greed

HSA(A version of this Health Alert was published by Forbes.)

Perhaps it is just unfortunate coincidence, but Hillary Clinton’s proposal to impose federal controls on prescription drug prices was perfectly timed to ride the public outrage over a hedge-fund manager turned pharmaceutical executive, Martin Shkreli, who raised the price of a  decades-old drug drug from $13.50 per pill to $750.

Mrs. Clinton lumps all nominally expensive prescription drugs into the same category of so-called “specialty drugs.” However there is a world of difference between Mr. Shkreli’s Daraprim and specialty drugs like Sovaldi and Harvoni. The latter are newly invented medicines that required many years and huge amounts of capital investment to achieve therapeutic advances for patients suffering Hepatitis C that radically increase their quality of life. They comprise intellectual property protected by patents, which allow the drug makers to compete without fear that their innovations will be copied immediately by manufacturers who made no comparable investment in R&D.

21st Century Cures Act Passes House with Overwhelming Bipartisan Support

This morning, the U.S. House of Representatives passed (344-77) the 21st Century Cures Act. This is a monumental achievement, designed to fundamentally restructure the Food and Drug Administration and thereby reverse the staggering decline of productivity in medical research and development.

The bill started as a bipartisan effort in the House Energy & Commerce Committee, where Republican and Democratic leaders moved beyond rhetoric and went right back to the basics, questioning the role of the federal government in spurring innovation and regulating our access to medical technology.

Unfortunately, their achievement is tainted by another fiscal glitch. For the third time (after the Medicare “doc fix” and repeal of the medical device excise tax), the House has voted for spending while weakening its commitment to offsetting cuts.

Caution: 21st Century Cures Act Has A Suspicious Payment Plan

prescription-drugs(A version of this Health Alert was published by Investors Business Daily.)

The House of Representatives is scheduled this week to consider the 21st Century Cures Act (H.R. 6), a health policy bill designed to improve the economic incentives and streamline the process for inventing new medicines.

We applaud the act. It will go a long way to solving the crisis in pharmaceutical innovation. But we caution against the mandatory funding proposal in the bill and urge Congress to authorize and appropriate the funds instead of creating a new, mandatory spending program.

FDA Approves First Biosimilar Drug; Still No Guidance on Names

The Food and Drug Administration has approved the first biosimilar therapy in the U.S.:electronic-medical-record

Many newer biotech drugs cost more than $100,000 per year, and together they account for nearly 30 percent of all U.S. drug spending. Five of the top 10 U.S. drugs by revenue are biotech medicines, according to IMS Health. Since their introduction in the 1980s, biotech drugs haven’t faced generic competition because the FDA did not have a system to approve copies.

In 2012, the FDA laid out a regulatory pathway to approve so-called “biosimilars.” That’s the industry term for generic biotech drugs, indicating they’re not exact copies. For years the biotech industry staved off competition by arguing their drugs were too complex to be reproduced by competitors. (Matthew Perrone and Linda A. Johnson, Associated Press via Denver Post)

Colorado Patients Win the “Right to Try” New Medicines Before the FDA Approves Them

Earlier this month, Colorado governor John Hickenlooper signed the nation’s first “right to try” law. The law allows a patient suffering from a disease, for which no medicine has been approved by the FDA, to try an experimental new medicine before the FDA approves it. The law allows, but does not force, drug-makers to provide their experimental drugs to patients. Other states, such as Louisiana and Missouri, are set to follow.

These patients are in dire straits. They suffer from diseases for which there is no other cure, and have short life expectancies. Most of us cannot imagine being in their position: They are willing to take far greater risks than most would accept, in their search for a cure.

Although the Food and Drug Administration (FDA) has an exemption for “compassionate use”, that exemption requires jumping through too many bureaucratic hoops to be useful. So, scholars at the Goldwater Institute developed the idea of state “right to try” laws that would enable residents to use experimental new drugs without FDA approval.

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