Not surprisingly, the pharmaceutical industry has been cooking up
responses to counter public outrage.
Rather than simply charging less, the industry is pushing for watered-down safeguards it claims will lower development costs and get patented drugs to market sooner and cheaper. It will deploy 1,200 lobbyists
to try to pass the 21st Century Cures Act. This bill has already passed the U.S. House of Representatives and will have its companion bill introduced in the Senate.
This initiative is being sold as enabling new cures to treat rare and difficult-to-treat diseases by increasing funding for biomedical research at the National Institutes of Health. But, at the same time, the pharmaceutical industry will be able to use this bill to undermine FDA safety requirements by making it easier to get their drugs approved more quickly. The industry blames rising drug development costs on the FDA's drug approval process, which it says is too lengthy.
These concerns don't stack up.
Investing in scientific research is, of course, a no-brainer. But the Cures Act will not only do that. Under the bill, research funding would be increased at the expense of lowering patient protections
and reducing access for affordable medicines.
A key responsibility of the FDA is oversight to ensure that the risks of new drugs and medical devices don't outweigh the benefits.
Well-designed Phase III clinical trials conducted by pharmaceutical companies to get their drugs approved by the FDA are critical for weeding out unsafe and ineffective drugs. More than a third of the drugs that enter Phase III testing fail to gain FDA approval for this reason.
One of the main advocates behind the 21st Century Cures Act, The Manhattan Institute, cites
drug development costs of Phase III clinical trials as a barrier to medical innovation and rising costs.
But the FDA is not a roadblock for drug discovery or for fast approval. As one former high-level official recently told Pro Publica
, most drugs that go into studies fail not because FDA is too strict but because the medications don't work.
Let's remember the FDA's responsibility is to safeguard the public. Inadequate oversight or changes that undermine safety standards can take a human toll
For example, in 1999, the FDA approved Merck's Vioxx, a painkiller. Five years later, Merck withdrew the drug from the market after a clinical trial revealed that it increased heart attack and stroke risks
. But millions of Americans had already taken Vioxx, and by 2006, lawsuits piled up. Research estimated that 88,000 Americans had heart attacks from taking Vioxx, and 38,000 of them died
. By November 2007, Merck announced it would pay $4.85 billion to settle 27,000 lawsuits over Vioxx. At the time, it was the largest drug settlement ever.
At a time when we need to offer solutions to reduce the rising cost of prescription drugs, the irony is that the pharmaceutical industry's push for the 21st Century Cures Act will actually increase
The bill allows pharmaceutical companies to charge high prices for many brand name drugs for a longer period. One provision allows companies to market drugs six months longer than currently permitted without generic drug competition. Since generics are cheaper and effective versions of medicines, patients and taxpayers lose out
The Congressional Budget Office estimates that over the next 10 years, this provision will cost the federal government $869 million
to pay for treatments. That estimate is low. According to new analysis from Public Citizen
, the actual cost could approach $12 billion. This is one heck of an expensive marketing perk for pharmaceutical companies.
The 21st Century Cures initiative is a big step backward. It adds to the rising costs of prescription drugs
gripping the nation.
For example, Medicare will likely spend more than $9 billion
on treating Hepatitis C this year, twice the amount it spent in 2014. Because of drug costs, the Veterans Affairs Department is restricting treatment
for patients that desperately need it during the late stage of their disease. Most states are alarmed with the possible $55 billion
price tag to cover Hepatitis C patients in their Medicaid and prison rolls. Some Medicaid programs are covering treatments
only for patients with advanced liver scarring because of disease. This is rationing at its worst, a heartbreaking trend.
Over the coming months, the national drug pricing debate will only deepen. More than 90% of Iowa voters
want presidential candidates to hold down the rising cost of prescription drugs.
As a response, the pharmaceutical industry will make exaggerated claims and call for reforms gutting safeguards in the name of reducing drug prices. It will contest how its products save lives, extolling the virtues of their government-backed monopoly pricing power that in reality exploits our poor and sick. The 21st Century Cures Act will be included in this campaign.
Yet this initiative does nothing to relieve our pain and slow down costs. In fact, it will make matters worse. Don't be fooled by the pharmaceutical industry's latest gimmick. It would be a mistake for the Senate to fall for their trick.