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Lawmakers lambaste FDA chief over fatal outbreak

Appearing under subpoena before a House panel, the co-owner of the compounding pharmacy linked to the meningitis outbreak that has killed more than 30 people took the Fifth Amendment and refused to answer questions Wednesday.

And in the first congressional hearing on the tainted-drug scandal, lawmakers clashed with Food and Drug Administration Commissioner Margaret Hamburg about why the crisis hadn’t been prevented — and whether her agency had, or would use, its powers to prevent another public health tragedy.

Barry Cadden, a co-owner of the New England Compounding Center, took the Fifth Amendment and refused to answer a series of questions from Republicans and Democrats alike. So far, 32 people have died and 438 illnesses have been linked to three lots of injectable steroids made by NECC. The toll is likely to rise.

The hearing began on a bipartisan and personal note, as many members of the Energy and Commerce Subcommittee on Oversight and Investigations mentioned people from their districts or states who had been sickened or killed in the outbreak of fungal meningitis. The widow of one early victim testified about her loss and her bewilderment that injections meant to kill her husband’s back pain as he recovered from an accident had instead killed him.

But the questioning turned tough and skeptical when Hamburg said the agency needed clearer legal authority to regulate these compounding pharmacies, which act more and more like regular drug manufacturers but don’t fall under all the same regulatory requirements.

But lawmakers are divided about whether the agency needs more powers or needs to better use the powers it has. Some committee members lashed out, accusing the agency of failing to take action based on the documented problems at the NECC. They also said they were frustrated because the FDA had not yet handed over email, memos and other documents about the NECC case.

Hamburg said FDA’s authority is ambiguous and incomplete. She said the agency is not adequately empowered to address the “gray area” between traditional drug manufacturers and compounders who have gone beyond their traditional small-scale role of customizing prescriptions for individual patients and now make and ship large batches of drugs.

Hamburg argued that conflicting court rulings about FDA authority have led to different rules in force in different parts of the country. “The fact that we have unclear, contested and limited authorities, ambiguities in the law, a crazy quilt of legal authorities, has caused us to be very reactive,” she said.

She said the law needs to be updated to give FDA specific authority to inspect compounding pharmacy facilities, review records, compel the labeling of compounded drugs and require reporting of any adverse events.

Hamburg estimated there are about 3,000 compounding facilities nationwide that produce sterile drugs like those implicated in this outbreak. There are about 5,600 traditional drug manufacturers that clearly fall under the FDA’s full purview.

Lauren Smith, the interim health commissioner of Massachusetts, who also faced tough questions, said sterile compounders should be required to report data on how much they produce and where they distribute drugs. She said they should also be required to notify all relevant state or federal regulators of any investigations under way. She said the Colorado Board of Pharmacy had been investigating NECC in 2011, but Massachusetts wasn’t aware of it.

But Rep. Joe Barton (R-Texas) was among those who suggested that FDA has the authority it needs to regulate compounding pharmacies like NECC. “You can take a horse to water, but you can’t make him drink,” Barton said in opening comments. “Well, you can take a regulator to a problem, but you can’t make him regulate it.” He added: “You’ve got to get a regulator to use the authority the states have given them and the Congress has given them.”

Several Republicans and Democrats also blasted Hamburg for refusing to answer direct questions about whether the FDA could have seized drugs at the facility after a 2006 FDA warning letter to NECC and a series of safety questions dating back to 1999.

“If you do not cooperate, you are going to have a very hard time with this committee,” warned Rep. John Dingell (D-Mich.). He told her that by being defensive, “I would assure you that you are putting your head in the noose.”

Hamburg would not say definitively whether she could stop another NECC-like incident without more legislation and said unless FDA and Congress worked together, “there will be more” problems, she said.

Rep. Henry Waxman (D-Calif.) tried to shift the focus away from who had failed to who had made the tainted drugs. “First of all, let’s not lose sight of the wrongdoing as we go around blaming the regulator.”

“The regulators deserve blame, but the primary blame in my mind is the company,” Waxman said.

He added that if Congress gave the FDA more authority, the agency would also need more money. But he also criticized the agency, saying he would have had FDA intervene in the NECC case whether its authority was clear or not.  

Posted to: Federal Government Health News Politico

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The last sentence is scary

"But he also criticized the agency, saying he would have had FDA intervene in the NECC case whether its authority was clear or not."

Every day there is a story in which one government official or another is advocating ignoring or actually ignoring the law to achieve an outcome THEY desire. Or course, they are taking their lead from POTUS who has shown his disdain for the rule of law and Constitution (which he has sworn to uphold) several times.

It is very concerning

But this administration has already demonstrated dozens of times that adherence to law or the constitution is voluntary.

"Do like we say, not like we do."

And John Dingell said noose!

So he's just like George Allen.

Wait a minute!

We whine about government overreach and now we whine that the FDA didn't intervene in an area (compounding pharmacies) that Congress hasn't given it the authority to regulate. More political grandstanding.

Mitt Romney

Mitt Romney's administration in Massachusetts allowed this company to stay in business even after they were caught using unsanitary practices. This is what less regulation of corporations leads to Republicans, death and economic ruin.

Take a rest W

I guess you are now going to blame Romney for every problem this administration has for the next 4 years. I can't imagine why anyone on either side would ever want to hear his name again.

Nobody does want to hear his name, however

You have to give credit where credit is due. Romney let this company off the hook, and now it's killed people.

Owner should be brought up on murder charges.

Do more with less.

And GOP will give you less.
From a news article:
"Under the House GOP proposal to reduce non-defense discretionary spending, the FDA’s $2.3 billion budget (which makes up a whopping 0.07 percent of the overall federal budget) will be reduced by 20 percent, imperiling the jobs of 3,000 inspectors.
And that’s child’s play compared to the 40 percent hit the FDA would be in for under the House Republican Study Committee’s spending plan, or the 62 percent cut it would see under Sen. Rand Paul’s (R-KY) budget. And, Republicans are also threatening to defund the recently passed Food Safety Modernization Act, which boosts the inspection abilities of the FDA, even though it will save taxpayers money in the long run.

You get what you pay for!

FSMA

The FSMA is the legislation that, except for a last-second amendment when someone actually read what they were about to pass, would have prohibited a neighbor from giving you a couple of tomatoes over the fence without having an inspection and permit.

NC WANTS TO DEAL WITH THIS THEMSELVES

This is one more thing NC and other states who no longer want to part of the Union will have to handle on their own (or won't since they don't want to pay taxes) - what a scary thought for the citzens of those states. This is one more example of "we want less government" but we "want government to protect us". Can't have it both ways. I also don't want to hear that the government didn't do such a good job, because maybe (and we don't know for sure yet) they didn't do a good job this time, but how many, many, other times has the FDA saved lives. No FDA means contaiminated drugs, mad cows being sold in your supermarkets, fruits and vegatables that have been sprayed with harmful pesiticides and the list goes on.

As usual

The House republicants are a special breed of homo erectus, not quite capable of human thought. They always whine and fault government regulation, now we have an example of what the precious private sector will do if not watched. For all the blow hard right wingers please refuse to use any FDA approved drug, use only the untested and unregulated. By so doing we will marvel at your courage of convictions and tou will validate by deed your opposition to those horrible government regulations. This I would truly like to see.

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