Category: Drugs

Rational Drug Prices Require Rational FDA Regulations

The House has passed and the Senate is expected to pass the pork barrel-bloated, 21st Century Cures Act. Aside from $6 billion worth of pork, the Cures Act would reform the drug approval process at the U.S. Food and Drug Administration (FDA). A rational path to drug discovery is badly needed. Once a drug finally makes it through the regulatory process to approval, it is guaranteed years of monopoly pricing due to the plethora of regulatory barriers that inhibit competition.

Dec 02, 2016 | Leave a Comment | by Devon Herrick

Opioid Mouth Spray Costs 200 Times More than Patch

The drug fentanyl — which is up to 50 times stronger than heroin — is available in generic form. It is also a highly addictive street drug, manufactured in back-alley labs and laced in heroin to boost its potency. Fentanyl is used to treat extreme chronic pain that is unresponsive to other opioid pain relievers, such as breakthrough pain cancer patients often suffer. A fentanyl transdermal patch costs from $5 to $12 depending on the dose per hour. A 12 micrograms (mcg) per hour patch retails for about $5 and offers 72 hours of pain relief, whereas the 100 microgram per hour patch is about $12 with GoodRx coupon. Sounds like a bargain; pain-free bliss for $2 to $4 a day. That works out to about $50 to $125 per month.

Nov 23, 2016 | Leave a Comment | by Devon Herrick

Big Pharma and Access to Medicines

Having written critically about a decision made by Doctors Without Borders /Médecins Sans Frontières (MSF) to reject a donation of vaccines by Pfizer, Inc., I am grateful for a new report which ranks research-based pharmaceutical companies on a number of measurements of how they make medicines available to patients in low-income countries.

Jointly funded by the Bill & Melinda Gates Foundation and British and Dutch taxpayers, the Access to Medicine Index ranks 20 large drug makers. It is a very thorough report:

Nov 21, 2016 | Leave a Comment | by John R. Graham

FDA Can’t Hire Workers, Despite Six-Figure Salaries

Would a starting salary of over $160,000 turn you off? Well, maybe if you had a scientific PhD and had to wait four months before the employer could decide whether to hire you or not, you would find a spot elsewhere.

This is the situation the Food and Drug Administration finds itself in, according to the Washington Post:

The Food and Drug Administration has more than 700 job vacancies in its division that approves new drugs, and top officials say the agency is struggling to hire and retain staff because pharmaceutical companies lure them away.

“They can pay them roughly twice as much as we can,” Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research (CDER), said at a rare-diseases summit recently in Arlington, Va.

(Sidney Lupkin & Sarah Jane Tribble, “Despite ramped-up hiring, FDA continues to grapple with hundreds of vacancies,” Washington Post, November 1, 2016.)

Nov 07, 2016 | 2 comments | by John R. Graham

They Can’t Even Give It Away: Global Charity Rejects Free Vaccines

Doctors Without Borders /Médecins Sans Frontières (MSF) has decided to reject a donation of one million doses of pneumonia vaccine from Pfizer, Inc. The global health charity’s convoluted reasoning goes like this:

There is No Such Thing as “Free” Vaccines

Pneumonia claims the lives of nearly one million kids each year, making it the world’s deadliest disease among children. Although there’s a vaccine to prevent this disease, it’s too expensive for many developing countries and humanitarian organizations, such as ours, to afford.

Free is not always better. Donations often involve numerous conditions and strings attached, including restrictions on which patient populations and what geographic areas are allowed to receive the benefits.

Critically, donation offers can disappear as quickly as they come. The donor has ultimate control over when and how they choose to give their products away, risking interruption of programs should the company decide it’s no longer to their advantage.

This remarkable document goes on to praise GSK, a competitor of Pfizer’s, for having declined to offer pneumonia vaccines for free, but instead offer them for $3.05 per dose to all humanitarian organizations. I don’t know about you, but I will take free over three bucks any day.

Oct 25, 2016 | Leave a Comment | by John R. Graham

Mixed News on Generic Drug Approvals

A response to expensive patented medicines is generic competitors. The U.S. has struck a pretty good balance between innovation and low prices through the Hatch-Waxman (1984) Act, which specified patent terms for newly invented medicines, and a pathway for generic competitors to enter the market after a period.

One obstacle to generic entry in recent years was a very slow approval process at the Food and Drug Administration. This led to a backlog, which was unexpected because one important benefit of Hatch-Waxman was that generic competitors did not have to replicate the expensive clinical trials innovative drug-makers had to carry out to receive the FDA’s approval.

The FDA’s Office of Generic Drugs (OGD) considers approving generic copies of drugs upon receipt of an Abbreviated New Drug Application (ANDA) from the manufacturer. The system changed under a law passed in 2012, the Generic Drug User Fee Act (GDUFA). Recent data show improvement:

Oct 17, 2016 | 1 comment | by John R. Graham

EpiPen Maker Lobbied U.S. Preventive Services Task Force

According to a report in the Washington Examiner, drug maker Mylan lobbied the U.S. Preventive Services Task Force to require insurers to pay the full price of EpiPens by deeming the drug delivery device a preventative measure. Under the Affordable Care Act, health plans must cover preventive services 100% without cost-sharing regardless of whether deductibles have been met. EpiPens are used by people with severe allergies who go into anaphylactic shock. They are not used to prevent anaphylaxis, they treat the symptoms once it occurs. For example, under ACA regulations, a flu shot is a preventive medicine. Once you have the flu, seeing your doctor for Tamiflu would be a treatment, not a prevention.

Oct 13, 2016 | 3 comments | by Devon Herrick

Who Benefits From The “Right to Try” Experimental Medicines?

The Goldwater Institute has had great success getting states to pass “Right to Try” laws. Right to Try allows a desperately sick patient to take an experimental new medicine before the FDA has approved it.

Since I last wrote about this policy in November 2014, 31 states have passed Right to Try. Further, U.S. Senator Ron Johnson (R-WI) has tried to get a federal Right to Try law through the U.S. Senate.

However, there has been push-back. According to Allison Bateman-House of NYU Langone Medical Center, “there is no confirmed instance of anyone getting a drug through Right to Try.” Jonathan Friedlaender, a survivor of advanced metastatic melanoma, has written a compelling essay in Health Affairs, which concludes Johnson’s proposed federal law would not improve access to experimental medicines.

The problem has two parts:

Oct 04, 2016 | 5 comments | by John R. Graham

Hillary’s Campaign to Lower Drug Costs is a Real Downer

Spending on prescription drugs has grown tremendously over the past few decades. This is mainly due to the increase in the number of diseases and conditions treated using drug therapy. The truth is: most drugs are dirt cheap! However, a small portion — maybe 1 or 2 percent — are rather costly. As a result of that small percentage, drug prices have become a campaign issue accompanied by plethora of bad ideas.

Early in his campaign, Donald Trump even came out with some doozies, such as having the government negotiate drug prices for Medicare and importing drugs from abroad (that is: importing other countries’ price controls). He has since ceded these populist talking points to Hillary in favor of free-market ideas. He now advocates getting government out of the way, allowing competition to flourish. He understands that bureaucratic red tape at the U.S. Food and Drug Administration often prevents competition from holding drug prices in check.

Hillary Clinton is another story.

Sep 23, 2016 | 2 comments | by Devon Herrick

EpiPen: A Case Study In Health Insurance Failure

I recently wrote a post describing EpiPen as a “Case Study in Government Harm,” describing how the government had made it possible for the manufacturer to increase prices of the life-saving drug multiple times without fear of retaliation. It is also a case study in how health insurance distorts our choices and increases their cost. I learned this by following an Internet advertisement for EpiPen down its rabbit hole.

The ad induced me to download my “EpiPen Savings Card” which would ensure I paid nothing for my EpiPens (up to six, according to the ad):

However, I had to answer a skill testing question first: What was my insurance coverage? As you can see from the screenshot below, when I answered I had no insurance, the EpiPen savings card was figuratively ripped from my hand:

Sep 13, 2016 | 8 comments | by John R. Graham

Category: Drugs

Rational Drug Prices Require Rational FDA Regulations

Opioid Mouth Spray Costs 200 Times More than Patch

Big Pharma and Access to Medicines

FDA Can’t Hire Workers, Despite Six-Figure Salaries

They Can’t Even Give It Away: Global Charity Rejects Free Vaccines

Mixed News on Generic Drug Approvals

EpiPen Maker Lobbied U.S. Preventive Services Task Force

Who Benefits From The “Right to Try” Experimental Medicines?

Hillary’s Campaign to Lower Drug Costs is a Real Downer

EpiPen: A Case Study In Health Insurance Failure

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Category: Drugs

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