Highlight text to annotate itX
FARRON COUSINS: The US Supreme Court recently gave generic drug manufacturers a free pass
to poison and kill American consumers. But even before that ruling, generic drug companies
were subject to few, if any, federal regulations. Joining me now to discuss this is Attorney
Howard Nations. Howard, I think most consumers aren't aware of the fact that recently the
US Supreme Court pretty much completely took away any way for consumers to hold generic
drug manufacturers responsible. HOWARD NATIONS: They did. And that's particularly
important, because 75 percent of drug sales in the United States are generic drugs. This
came to a head last month in the Bartlett decision in the US Supreme Court. Karen Bartlett
is a very nice lady who had shoulder pain. She went to the drug store to buy a simple,
generic painkiller. As a result of that painkiller, clearly, her life was destroyed. Her life's
been described now as "a living hell." She went to trial before a New Hampshire jury
in federal court in New Hampshire, applying New Hampshire state law. The jury awarded
$21 million for her damages, which was really not a generous award at all, because the future
care she's gonna require is gonna take up most of that. That case then went to the Supreme
Court, and it gave the Roberts court the opportunity to finish what they started in the Mensing
decision, which is granting total immunity to generic drug manufacturers. In continuing
their customary disdain for the American jury, the Roberts court the Roberts majority overturned
the jury award and held that the New Hampshire law was pre-empted by an FDA rule.
COUSINS: Right, and those FDA rules are almost saying that there are no rules, and that's
what's so ironic about them turning it back over, saying the FDA rules are going to trump,
because as we've seen a great new Public Citizen report came out recently. There really aren't
that many rules and regulations that are put in place that apply to generic drug manufacturers.
NATIONS: No, they pretty much get a free reign. The pharmaceutical industry has been trying
to buy a free reign in Washington, and so far, they've done a very good job. There are
three major consequences of this Bartlett decision the first is generic drug manufacturers
have virtual immunity. But in doing so, in acquiring immunity, they also have no incentives
to take unsafe drugs off the market or to issue warnings about unsafe drugs that might
hinder their sales. The second consequence is that citizens, such as Karen Bartlett,
are left without a remedy. But the third major, and biggest of these three of these consequences,
is that there's now a major safety gap in generic drug use. Generic drugs are dangerous.
And as you said, the Public Citizen identified over a period of January 2008 to March 2013,
they identified 53 different drugs that had to be black-boxed. They had to have a black
box warning issued after they became generic. COUSINS: I think one of the most astounding
things that people need to be aware of is that with generic drugs, they are not allowed
to go and change their label when new problems arise. They have to wait for the name brand
drug to do that. Then they're allowed to change their label to reflect what the name brand
has done. And in a lot of cases, the name brand is no longer on the market. So, what
happens then? NATIONS: The name brand drug no longer has
an incentive, as a general rule, after generics come on the market and take a major portion
of the market share. The brand name drug has no incentive to come in and spend a lot of
money to go through the CBE process or to go through any process to issue new warnings.
So, the result is with this ruling there are no warnings. There are no changes and warnings.
There are no taking of the defective drugs off the market. And drugs can be on the market
for 40 and 50 years, and still be found to be dangerous. For example, Finnegan was approved
by the FDA in '51. Fifty-three years later, in 2004, it was black-boxed. Reglan was approved
in '79. Thirty years later, in 2009, black box warning. Darvon and Darvocet, approved
in '57, and in 2010, 53 years later, black box warning. Prozac, which is still on the
market, was approved in '87, black-boxed in 2004. So, the fact that it's been on the market
a long time doesn't mean that it's got a safety history, because it doesn't.
COUSINS: And I think one of the things that is so important about this a lot of American
consumers, as you pointed out earlier 75 percent are taking generics. And that's either because
their insurance will only cover generics if one is available, or in a lot of cases, people
who don't have insurance they can't afford this name brand drug that is selling for $300.00
a bottle vs.the generic that might sell for $20.00 or $30.00. So, they're dependent upon
these, and again, this is mostly the pharmaceutical industry preying on low and middle income
Americans. And that's what is so important about this story. The FDA is not doing anything.
Is there any action at the FDA to fix this problem?
NATIONS: Well, the status today is that the FDA finally, after Bartlett, has placed this
rule change for the CBE rule on the calendar for September. But the FDA has known about
this Public Citizen has had a longstanding petition pending before the FDA asking them
to make this change long before Mensing, before Bartlett. They've been begging them to please
make this rule change, and they've delayed, and delayed, and delayed. Now, after Bartlett,
they say, "Okay, we'll put this rule change on the calendar for September." But the FDA
has a long history of protecting drug companies. So, we'll just have to wait and see what happens
in September. I'll believe it when I see it. COUSINS: Well, Howard, thank you very much
for staying on this issue for us.