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Thursday
Jun272013

ALG - Supreme Court decision puts generic drug labeling in legislative bullseye

June 26, 2013, Fairfax, VA—Americans for Limited Government today delivered a letter to House Speaker John Boehner today signed by leaders of eight major organizations urging his "opposition to legislation that would drive up healthcare costs and line the pockets of trial lawyer by opening generic drug manufacturers to frivolous lawsuits."

The letter signed by leaders of Americans for Limited Government, the Competitive Enterprise Institute, the Hispanic Leadership Fund, American Commitment, King Street Patriots, LessGovernment.org, Independent Women's Forum and Congress On Racial Equality is particularly relevant given today's Supreme Court decision in Mutual Pharmaceutical v. Bartlett.

One of the underlying cases for today's decision was the PLIVA, Inc  v. Mensing case in 2011 where the Court held that it was impossible for generics to change (much less strengthen) safety warnings to comply with state law and still comply with the federal law's requirement that their labeling be "the same as" FDA-approved brand drug labeling.

Nathan Mehrens, president of Americans for Limited Government explained, "Attempts by the trial bar to open up generic drug manufacturers to liability because they followed U.S. Food and Drug Administration labeling standards are absurd on their face.  If Congress allows this to occur, those who depend upon low cost generics will likely see the prices skyrocket as attorneys across the nation go wild suing manufacturers for following federal law."

The letter asks the Speaker to "actively oppose such legislation when it is introduced and stop any momentum that it might hope to gain."

It is anticipated that legislation overturning Mensing will be introduced in both the U.S. Senate and the House of Representatives.

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June 26, 2013

 

The Honorable John Boehner

Speaker of the House

U.S. House of Representatives

Washington, DC 20515

 

Dear Mr. Speaker:

On behalf of the organizations listed below, we urge opposition to legislation that would drive up healthcare costs and line the pockets of trial lawyer by opening generic drug manufacturers to frivolous lawsuits. Although Congress should be considering policies that encourage manufacturing and jobs, they are instead bowing to special interest lobbyists and trying to circumvent the Supreme Court.

In 2011, the U.S. Supreme Court found that federal law forbids claims under state law by plaintiffs who allege that generic drug manufacturers failed to warn adequately of the risks of their products. In PLlVA, Inc. v. Mensing, the Court held that it was impossible for generics to change (much less strengthen) safety warnings to comply with state law and still comply with the federal law's requirement that their labeling be "the same as" FDA-approved brand drug labeling.

We must stress what this means. Brand and generic drugs must have the same label containing the same warnings. The Court did not lessen the safety and reporting obligations for generic drug manufacturers. The cases considered by the Supreme Court involve defendants that suffer from a condition that was in fact warned on the label, and the court is being asked to second guess whether the warning was sufficient or the label was designed properly.

The effect of Mensing is that manufacturers that label their products in compliance with FDA regulations, including all warnings as determined by the agency, cannot be sued for "failure to warn." This ruling, as you can imagine, did not sit well with the trial bar, which would like Congress or the FDA to pave a superhighway to state courthouses.

Now, as the Supreme Court once again considers a similar case with a decision due by June, the trial lawyers are trying to convince a few Members to introduce legislation that would overturn the court's earlier ruling and circumvent any new judgment. The proposed bill would give each generic manufacturer the ability to change their label in an effort to simply subject these manufacturers to state tort claims even if they have followed all current regulations and federal laws.

This is a transparent trial lawyer ploy. The cost and burden of litigating these cases will result in increased pharmaceutical prices and force companies to spend monies that could otherwise be devoted to research and development, jobs and manufacturing.

Our healthcare system is struggling greatly under the weight of Obamacare, a law that makes the government a larger purchaser of drugs than ever before. Costs are increasing, premiums are rising at an alarming rate, and our tax obligation to support this program in addition to our out-of-pocket expenses is ever increasing. Exacerbating these problems by passing legislation which will move money from healthcare to trial lawyers is not the solution.

This bill would become one of the biggest trial lawyer bonanzas in recent history. We ask you to actively oppose such legislation when it is introduced and stop any momentum that it might hope to gain.

Sincerely,

Nathan Mehrens                                             Sabrina Schaeffer

President                                                         Executive Director

Americans for Limited Government              Independent Women's Forum

 

Greg Conko                                                    Mario Lopez

Executive Director                                          President

Competitive Enterprise Institute                    Hispanic Leadership Fund

 

Catherine Engelbrecht                                   Niger Innis

President                                                         National Spokesperson

King Street Patriots                                        Congress On Racial Equality

 

Phil Kerpen                                                     Seton Motley

President                                                         President

American Commitment                                  LessGovernment.org

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Americans for Limited Government is a non-partisan, nationwide network committed to advancing free market reforms, private property rights and core American liberties. For more information on ALG please call us at 703-383-0880 or visit our website at www.GetLiberty.org.

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