Tag: "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.

Opioid Mouth Spray Costs 200 Times More than Patch

become-richThe 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.

Big Pharma and Access to Medicines

prescription-drugsHaving 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:

PPI: Health Prices Tame, Inflation Flat

BLSOctober’s Producer Price Index was flat. However, prices for most health goods and services grew slowly, if at all. Seven of the 15 price indices for health goods and services declined. The major exception was prices for dental care, which increased 1.5 percent. Dental care is dominated neither by government nor private insurance, so dental price increases are not explained by NCPA’s usual theory of health inflation. I addressed dental price increases in a previous article.

Prices of pharmaceutical preparations for final demand increased 0.4 percent, but that was in line with all goods for final demand. Prices for construction of both health facilities and other buildings increased 0.7 percent. This bears closer watching as President-elect Trump promises more spending on infrastructure, including hospitals.

Prices of health goods for intermediate demand, especially medicinal and botanical chemicals, and biological products, actually dropped. Perhaps this will flow through to prices of pharmaceutical products but that has not previously been the case.

Over the last twelve months, prices of health goods and services have increased faster than overall PPI, which grew 0.8 percent. The tables are turned: 12 of 15 health categories experienced larger price increases than PPI did. Pharmaceutical preparations continue to stand out dramatically, having grown 8.4 percent.

(See Table I below the fold.)

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

Variety of Medicine in Pill BottlesWould 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.)

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

vaccine-shotDoctors 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.

Mixed News on Generic Drug Approvals

captureA 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:

PPI: Health Prices (Except Pharmaceuticals) Stay Tame As Other Prices Rise

BLSSeptember’s Producer Price Index rose 0.3 percent, a significant pick up. However, prices for most health goods and services grew slowly, if at all. Eleven of the 15 prices for health goods and services reported grew slower than the headline PPI. The major exception was prices for pharmaceutical preparations, which increased 1.2 percent, resuming a trend which I had hoped was breaking down. Further, prices of medicinal and botanical chemicals dropped 0.7 percent. So, price increases for pharmaceutical preparations are not coming from the ingredients.

However, over the last twelve months, prices of health goods and services have increased faster than overall PPI, which grew 0.7 percent. The tables are turned: 11 of 15 health categories experienced larger price increases than PPI did. Pharmaceutical preparations continue to stand out dramatically, having grown 8.1 percent. Nursing homes, for which prices rose 2.4 percent, might replace drug makers as the whipping boy for high health prices, but they have a long way to go.

(See Table I below the fold.)

The United Nations Report on Access to Medicines is a Public Health Hazard

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

Almost one year ago, the Secretary-General of the United Nations convened a High-Level Panel on Access to Medicines, which is world still suffering the burden of tropical diseases (such as river blindness, sleeping sickness, leprosy, and rabies.) According to World Health Organization, people in 185 countries needed treatment for neglected tropical diseases in 2014.

In the 21st Century, such numbers are shocking. However, the panel’s would have many harmful effects on the development of new medicines that benefit patients in both the developing and developed world. Indeed, it identifies the wrong culprit in the ongoing health catastrophe in the developing world.

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.