Drug Safety Bill Approved By House In Bipartisan Fashion

Healthy Living – The Huffington Post
Drug Safety Bill Approved By House In Bipartisan Fashion
WASHINGTON — The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.

The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed. The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration’s authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.

Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.

Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.

The Senate is working on similar legislation.

“We are near the resolution of last year’s deadly outbreak,” said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.

That panel’s top Democrat, Rep. Henry Waxman of California, said, “There is no question that this bill represents a step forward.”

Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies “is not strong enough to ensure the public safety.”

Green – The Huffington Post
Can Louisiana Gov. Bobby Jindal Make the Big Oil Lawsuit Go Away?
Last week, Garret Graves, speaking for Louisiana Governor Bobby Jindal, told the nominating committee for the Southeast Louisiana Flood Protection Authority-East that the Governor would refuse to approve the reappointment of John Barry and Tim Doody should the committee recommend the two currently serving commissioners.

The surprisingly candid announcement came from Graves in a public meeting in response to a lawsuit that the SLFPA-E filed against 97 oil, gas and pipeline companies demanding that the industry repair the damage it did to Louisiana’s coastal wetlands. Doody is president of the SLFPA-E and Barry is vice president and the chief spokesperson for the suit filed in July. According to the suit, the wetlands loss has increased the intensity of the storm surge and raised the cost of maintaining levees and floodwalls which are responsibility of the Authority East.

The reaction from the Governor’s office was swift and stinging, but held few meaningful objections. The protest started out with personal attacks on the members of the Flood Authority and the trial lawyers. The goal of the lawsuit, said Graves, is fame for the commissioners filing the suit and windfall of money for the trial lawyers. Personal attacks are usually a sign of a weak case.

Then objections evolved to non sequiturs. For example, Graves has claimed that the suit deflects attention away from the culpability of the Army Corps of Engineers, a claim that only obscures the issue at hand, namely that the oil and gas industry is responsible, according to the experts, for more than a third of the damage.

As noted by Barry, the Governor has failed to provide an answer as to what Big Oil is providing to Louisiana that is so valuable that we should turn a blind eye to the the degradation of our storm surge-killing wetlands.

So now, it appears that Governor Jindal plans to control the nominating process by appointing to the Flood Authority East only those who are opposed to the lawsuit. Well, if the Governor can control the process, why can’t the nominating committee control it? There are probably ways this can be done, but first a little history.

After Hurricane Katrina and the failure of the Army Corps of Engineers’ levees and canal walls, there was a prompt reaction from local citizens and elected officials. The widely held presumption was that the commissioners of the Orleans Levee Board were not paying attention to flood protection and were therefore, partly responsible for the flood disaster. Federally appointed experts eventually absolved them of wrongdoing, but in 2005, the OLB and other levee districts were presumed guilty and this prompted the One Levee Board campaign to garner statewide support for a new paradigm of levee board governance.

In his fifteen minute speech, Graves quite correctly told the eleven gentleman and one lady that the new levee board legislation was about removing distractions from the commissioners so they could focus on flood protection and also about replacing parochial parish flood control with regional multi-parish flood control. These things are true. But the legislation as written, said Graves, was not about insulating the levee boards from politics. This is also true. In 2006, the mantra of “no more politics” was a rally cry, an advertising slogan. It was not a legislative directive.

Furthermore, though few are aware, the legislation establishing the new levee board paradigm was the first ever in the country. No other state in the nation had similar legislation governing its levee boards which means the legislation had to be written from scratch. “I made it up,” said then Senator Walter Boasso from St. Bernard Parish in an email to the author. “There was no state model that we had taken this from.”

While a direct causal link between the actions of the pre Katrina levee boards and the catastrophic flooding has not been established, no one denies that the new legislation was needful and beneficial. In addition to creating regional governance, the legislation required commissioners to have professional experience including hydrology, engineering and civil engineering.

The spirit of the new paradigm was deftly described by Representative Tim Burns who actively supported SB 8 and SB 9 which created the Authorities East and West. In a February 27, 2006 email to his constituents, he wrote that the legislation was a “monumental step forward in centralization, unity, professionalism and coordination of area flood control efforts.”

The new levee board paradigm literally put Louisiana on the frontier of good governance, but it was crafted and passed at breakneck speed. So here we are today with original, never before seen legislation, meaning there was likely to be issues and problems. And there were.

A problem that surfaced immediately with the shiny new legislation was the difficulty of finding qualified applicants to meet the complex matrix of requirements. According to committee member Robert Travis Scott, this continues to be a problem today. Another issue which surfaced in 2011 was that the rules required burdensome traveling time for commissioners traveling from out of state. This prompted Louisiana State Senator J.P. Morrell to put the Governor on alert that he would vote against re-appointing two commissioners to the New Orleans Flood Authority citing the high cost of the flood experts’ monthly commutes.

Governor Jindal thinks he can control who is appointed to the Flood Authority East. But, what if the nominating committee stands up to the Governor? It is still possible for the committee to choose nominees this Monday and retain control of the process.

And while political insulation may not have been a founding goal of the new levee board paradigm, it may have been an accidental result. But one thing is certain. We shall see in the weeks and months ahead just how independent the commissioners of the Flood Authority East really are.

#alkalinity #alkalinitymovement #7.2 #sevenpointtwo

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