The Food and Drug Administration (FDA) last year had 4,036 generic drug applications waiting for approval. In October 2012, there was a backlog of 2,868 drugs. It now takes a median 47 months to approve a generic drug by the FDA – nearly four years.
What does this mean to the healthcare consumer?
First, it allows a drug company to continue selling their “brand name” drug because there is no replacement on the market. Brand name drugs are sold at incredible prices, pushed up by obscene profits, as well as constant advertising, plus promotion of drugs by medical professionals. To many in the health business, brand name drugs are the real money makers.
By comparison to the United States, the European FDA – the European Medicines Agency (EMA) – has just 24 generics awaiting approval. It takes about a year to get approval in Europe, one quarter the time of the U.S.
Why would it be faster to approve generics in Europe than here? The answer is that patients in America pay for their drugs, either directly or through health plan premiums. In Europe the government negotiates drug prices, because they are working to lower costs to benefit their citizens and reduce spending. It’s the difference between healthcare for profit or for the public good.
An odd provision of the FDA approval process is that the brand name drug manufacturer can introduce a generic of the same product, and they will not have to wait in line behind other pending products. An unfair advantage for brand name drug companies, this favoritism is why we see some generics that cost almost as much as the brand name drug – both coming from the same company.
Dr. James Baker, the CEO and chief medical officer of Food Allergy and Research Education, said this could deter other generic manufacturers from seeking approval.
In 2012 the government introduced new fees for the generic manufacturers. The fees were used to hire an additional 1,000 employees, put the Office of Generic Drugs on par with the Office of New Drugs, and moved it to the FDA’s main campus from four buildings in Rockville, MD.
The fees became part of the Prescription Drug User Fee Act, which required brand name drug manufacturers to pay fees to increase FDA efficiency. In the first three years, the FDA collected $1 billion from generic drug manufacturers.
The fees and changes were a failure. In four years only 1,551 generics have been approved.
Tasteless comment of the week:
During Saturday’s Women’s March in Washington, DC, Ashley Judd, 48, ranted:
I am not as nasty as racism, fraud, conflict of interest, homophobia, sexual assault, transphobia, white supremacy, misogyny, ignorance, white privilege. I’m not as nasty as using little girls like Pokemon before their bodies have even developed. I am not as nasty as your own daughter being your favorite sex symbol, like your wet dreams infused with your own genes. But, yeah, I’m a nasty woman, a loud, vulgar proud woman. I’m not nasty, like the combo of Trump and Pence being served up to me in my voting booth.
In December 1999, Judd (left, younger) became engaged to Scottish racing driver Dario Franchitti, who was driving in the Champ Car World Series. Since then, Franchitti has raced in IndyCar and NASCAR. They married in December 2001 at Skibo Castle. They have no children, with Judd telling the Sunday Mail that “it’s unconscionable to breed with the number of children who are starving to death in impoverished countries”
They divorced in 2013. – Wikipedia
Oppose Price as Secretary of HHS. Write your Senators
Social Security Works said today that Senator Thomas Edmunds Price wants to destroy Social Security and Medicare:
“Whether it’s means testing, whether it’s increasing the age of eligibility …. All those things ought to be on the table and discussed.” – Tom Price
Price’s extreme views on the future of Social Security, Medicare, and Medicaid, and his reported conflicts of interest as a Congressman show that Price is the wrong person to head the incredibly powerful department of Health and Human Services.
The Secretary of Health and Human Services oversees a $1 trillion budget, including Medicare and Medicaid, two programs which affect more than 100 million Americans.
One thought on “Americans suffer while drug companies make a fortune because FDA isn’t timely approving generics”
We need an anti-drug company czar, not a physician who talks about the quality of care and refuses to endorse the drug cost issue as a primary issue in healthcare!