Tag Archives: generic drugs

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

November 7, 2016 John R. Graham 2 Comments

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.)

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

Drugs

Mixed News on Generic Drug Approvals

October 17, 2016 John R. Graham 1 Comment

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: Continue reading Mixed News on Generic Drug Approvals →

Drugs

EpiPen: A Case Study In Health Insurance Failure

September 13, 2016 John R. Graham 8 Comments

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: Continue reading EpiPen: A Case Study In Health Insurance Failure →

Health Alerts

Health Care and the Budget Deal: Three Steps Forward, One Step Back

October 28, 2015 John R. Graham 5 Comments

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

Yesterday, the White House and Congressional leaders announced a last-minute budget agreement that avoids a so-called government shut-down for now. The deal has four health-related items, and is expected to reduce net federal health spending by about $4.5 billion over five years, and $15.5 billion over ten years. Overall, it is not a bad deal with respect to health care. However, some of its budget savings are fragile and it largely avoids reforms that will actually reduce the growth of health spending. Continue reading Health Care and the Budget Deal: Three Steps Forward, One Step Back →

Health Care Access

Drug Shortages Getting Worse

June 2, 2015 John R. Graham 2 Comments

Robin Miller, a 62-year-old oncologist in Atlanta with bladder cancer, was scheduled to receive a potentially lifesaving drug in December. But her doctor’s office called shortly before the appointment to say: “Sorry, we don’t have any. We can’t give it to you,” according to Dr. Miller.

The disruption was due to a global shortage of the drug, BCG, which arose after manufacturing problems at two of the few global suppliers. Without the drug, Dr. Miller feared her cancer would come back and she would have to have her bladder removed, a step she called “barbaric.”

The crisis illustrates the potentially grave consequences of a persistent problem in health care: drug shortages. The number of drugs in short supply in the U.S. has risen 74% from five years ago, to about 265, according to the University of Utah’s Drug Information Service, which tracks supplies. They range from antibiotics and cancer treatments to commodity items such as saline. (Peter Loftus, “U.S. drug shortages frustrate doctors, patients,” Wall Street Journal, May 31, 2015)

The U.S. government’s measures to mitigate this problem have failed because it has ignored NCPA’s conclusion that shortages result from too much, not too little control over the market for these drugs.

The government keeps tightening the screws on manufacturers, and the shortages keep growing.

See Devon Herrick’s testimony to the U.S. Senate in 2011 and my own study published in 2012.

Health Care Access

IS FDA Reporting Drug Shortages Adequately?

April 17, 2015 John R. Graham

For a number of years, there have been critical shortages of certain generic drugs for injection. These are often important cancer drugs. In 2012, I wrote a report that concluded over regulation by the Food and Drug Administration (FDA) was the primary cause of the shortages.

The President and Congress acted, but their actions did not result in improvement for over a year.

Today, the FDA claims to have improved the situation. However, an article in Health Affairs points out that the number of drug shortages reported by the FDA and the number reported by the University of Utah Drug Information Service (UUDIS), the leading private source of this data is diverging dramatically: Continue reading IS FDA Reporting Drug Shortages Adequately? →

New Health Care Law

Why the CBO Doesn’t Think Obama Health Reforms Will Reduce Health Care Costs

June 10, 2009 John Goodman 2 Comments

Generic drugs, preventive care, electronic medical records, comparative effectiveness research – these are supposed to save money. Right? Well, not exactly. In the latest issue of “The Government We Deserve,” Gene Steuerle explains why.

Interesting Links

Hits & Misses – 2009/5/5

May 5, 2009 John Goodman 4 Comments

Watch life expectancy and per capita income change over time. (H.T. to Jason Shafrin.)

Kristof over the top: the uninsured are 47 million potential Typhoid Marys.

Two new studies: generics don't work as well.

Interesting Links

Hits & Misses – 2009/4/21

April 21, 2009 John Goodman 3 Comments

Thousands of veterans put at risk by contaminated colonoscopy equipment (one has HIV; seven have Hepatitis C) at Miami VA hospital. System held as a model for the country by Paul Krugman and others.

Blue Cross study: People who choose high deductible plans are more savvy about controlling costs. They choose generics over brand name drugs and take better care of their health.

Poor and elderly Minnesotans on government health plans get worse care than those with private coverage. Even when treated at the same clinics by the same doctors.

Safeway employees with unhealthy behaviors pay 51% more for their health insurance. Employees must submit to an annual cheek swab to prove they are not smoking, have their cholesterol and blood pressure measured and be weighed yearly.

httpv://www.youtube.com/watch?v=t-idDbIfGvw

“As time goes by so slowly”

Interesting Links