Tag Archives: FDA

Policy Updates

Jeb Bush’s Health Plan

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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. Continue reading Jeb Bush’s Health Plan →

Policy Updates

FDA Driving Drug Prices into Stratosphere

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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). Continue reading FDA Driving Drug Prices into Stratosphere →

Health Alerts

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

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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. Continue reading Martin Shkreli A Creature of FDA Regulation, Not Pharma Industry’s Greed →

Policy Updates

21st Century Cures Act Passes House with Overwhelming Bipartisan Support

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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. Continue reading 21st Century Cures Act Passes House with Overwhelming Bipartisan Support →

Health Alerts

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. Continue reading Caution: 21st Century Cures Act Has A Suspicious Payment Plan →

Science and Other News

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) Continue reading FDA Approves First Biosimilar Drug; Still No Guidance on Names →

Policy Updates

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

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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.

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

Health Care Quality

Some New Medicines are Approved More Quickly than Others

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Joe DiMasi of the Tufts Center for the Study of Drug Development, and colleagues, have reviewed the time it takes for the FDA to review different types of new drugs.

seniors-and-prescriptionsFDA’s Neurology division, which approves drugs for Alzheimer’s disease, multiple sclerosis, Parkinson’s disease, and stroke, takes three times as long to approve drugs as the Oncology division. These differences cannot be explained by differences workload, the type and complexity of the drugs reviewed, or the safety of the drugs approved.

If the FDA could cut the performance gap between the divisions in half, the authors estimate that the cost of developing a new drug would decrease by $46 million — a savings that adds up to approximately $874 million per year.

Full report available from the Manhattan Institute.

Health Care Quality

Can States Overturn the FDA’s Limits on Compassionate Use?

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At National Review Online, Jillian Kay Melchior, reports on a cancer patient who has run out of therapies. There are medicines under development that might help, but drug-makers won’t let her have them under the FDA’s “compassionate use” doctrine.

ClVariety of Medicine in Pill Bottlesinical trials accept only “typical” patients — Mikaela’s rare form of kidney cancer has ruled her out, but for others in her situation, complications as common as diabetes or high blood pressure could also be reason for ineligibility. And the Food and Drug Administration’s approval process for “compassionate use” of an experimental drug outside of clinical trials is extremely arduous.

First, a pharmaceutical company has to be willing to provide the experimental drug — a high-risk proposition, given that an atypical result in an atypical patient can prompt the FDA to delay approval or require significant and expensive additional testing…And approval from a pharmaceutical company is just the first step. Next, patients and doctors must fill out an exhaustive paperwork disclosure to submit to the FDA, which is estimated to take at least 100 hours to complete. The FDA then begins a review, which is supposed to take no longer than a month — but if the agency’s reviewers have any additional questions or need more information, that 30-day clock is reset. Finally, the hospital’s institutional review board has to give approval — and if a patient is being treated at a small hospital that lacks such an administrative panel, the case has to be reviewed by a bigger facility, often one unfamiliar with the patient.

Continue reading Can States Overturn the FDA’s Limits on Compassionate Use? →