We Can’t Wait: Obama Administration Takes Action to Reduce Prescription Drug Shortages, Fight Price Gouging

President Obama signed an Executive Order on Monday directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging. The President’s order directs FDA to broaden reporting of potential shortages of certain prescription drugs and to further expedite regulatory reviews that can help prevent or respond to shortages. Under the President’s order, FDA will also work with to the Department of Justice, which will examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications.

In addition to signing the Executive Order, the White House announced the President’s support for bipartisan legislation (H.R. 2245 and S. 296) that will build on today’s actions to strengthen the FDA’s ability to prevent prescription drug shortages.

A small number of drugs in the U.S. experience a shortage in any given year, but the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010. While FDA successfully prevented 137 drug shortages between January 1, 2010 and September 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people.

These shortages could lead to price gouging, which has raised serious concerns. For example, the ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial – 80 times higher. A Premier healthcare alliance report released in August estimated that the typical gray market vendor marks up prices by an averaged 650 percent. At the extreme, a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a drug shortage.

“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,” said President Obama. “This is a problem we can’t wait to fix. That’s why today, I am directing my administration to take steps to protect consumers from drug shortages, and I’m committed to working with Congress and industry to keep tackling this problem going forward.”

Early notification of potential drug shortages can help prevent a shortage from becoming a crisis by allowing hospitals, doctors and manufacturers to take action to ensure medications remain available. Currently, the FDA can only require drug manufacturers to disclose the discontinuation of a critical drug when the drug is available through a single manufacturer. The President’s Executive Order directs the FDA to take additional steps to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances or other actions that could lead to critical shortages. These additional steps to increase early notification will help achieve some of the goals of bipartisan legislation supported by the President that would require all prescription drug shortages to be disclosed to the FDA in advance and give the FDA new authority to enforce these requirements.

The Executive Order also requires FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages.

These actions are just some of the steps the Obama Administration is taking to ensure patients have access to the lifesaving medicines they need. Today, the Obama Administration also:

  • Sent a letter to drug manufacturers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily disclose to FDA potential prescription drug shortages in cases where disclosure is not currently required by law.
  • Increased staffing resources for the FDA’s Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.
  • Released a report from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that assesses the underlying factors that lead to drug shortages, and an FDA report on their role in monitoring, preventing, and responding to these shortages.

While the causes and many of the solutions are outside of the FDA’s authority, including the need for additional manufacturing capacity in the private sector, the Administration will continue its ongoing work with manufacturers and other stakeholders to help address drug shortages.

View a fact sheet to learn more about prescription drug shortages and the Obama Administration’s announcements.

Senator Udall Applauds USDA Investment at NMSU

Funding will Support Hispanic Education

U.S. Senator Tom Udall (D-NM)  announced Monday that New Mexico State University will receive $800,000 to enhance programs that support underserved students and develop a skilled American workforce.

The funding, made possible through a competitive grant program within the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA), is awarded to institutions based on their commitment to meeting the needs of the Hispanic community. It will be used to mentor students who want to pursue a career in natural resource management.

“The education gap for Hispanic students is widening every day. This funding will invest in a critical group of underserved students to help them follow their dreams and earn a degree in natural resource management,” Udall said.

NMSU is one of 300 Hispanic Service Institutions nationwide and one of 13 institutions being awarded a grant of this kind.

October 31: News Roundup

Republican Herman Cain finds himself the center sexual harassment revelations. When Herman Cain was head of the National Restaurant Association two of his employees filed inappropriate behavior charges against Cain, Politico reports.

Emails obtained in the DOJ voting righs suit show that Rick Perry and Texas Republicans worked to purposefully limit Hispanic voters, TPM reports.

Secretary of State Hillary Clinton is credited with the leadership role that brought down the Libyan dictatorship of Mohamar Ghaddafi, the Washington Post reports.

The Citizen’s United ruling is taking its toll on the Republican Party’s leadership as outside groups eclipse the GOP in fundraising, the New York Times reports.

Flip-Flop Mitt Romney joins the ranks of climate change deniers, ThinkProgress reports.

After voter negativity erupts, Rick Perry flip-flops on his decision to quit the GOP debates, and will participate after all, Politico reports.

GOP presidential hopeful Herman Cain plays catch up with Mitt Romney and Rick Perry by piling up flip-flops of his own, the New York Times reports.

House GOP’s budget actions cost the nation over 370,000 jobs, ThinkProgress reports.

Newt Gingrich coming on as the next “flavor of the month” as Republicans desperately seek anybody-but-Romney, the Washington Post reports. Can Rick Santorum be far behind?

White House Hispanic Community Summit Opens Southern New Mexico Dialog

White House Hispanic Community Action Summit in Las Cruces

Senior members of the Obama Administration traveled to Las Cruces open a dialog with local southern New Mexico community leaders and engage with area citizens in a wide range of fields spanning education, immigration, health, and economic development.

The gathering, held on Thursday at the Las Cruces Convention Center, was designed to connect Administration officials from a wide array of policy areas with community-based Hispanic leaders, business owners, and local officials to discuss issues critical to the Hispanic community, New Mexico, and the nation.  The summit is part of a series currently taking place across the country.

The summit, which drew a large and diverse group of southern New Mexico participants,  was organized around an innovative open space dialogue where participants worked together and with others to define the agenda and shape the format.  The Las Cruces event was one of many in which the Administration has worked to keep its promises to seek direct feedback from local communities.


October 27: News Roundup

A growing number of Republicans are cautioning that extreme statements by the 2012 presidential candidates will hurt the party’s chances of winning in 2012. Mississippi Governor Haley Barbour has joined a group of Republicans who think that the candidates’ reliance on personal attacks will damage the party’s image. Even one of the candidates, Newt Gingrich, has spoken out against such pettiness, comparing some of the debate bickering to “some cafeteria in the seventh grade” the Atlantic reports.

When you put President Obama’s jobs plan up against the GOP proposal, there is not even a competition, reports the Los Angeles Times: “Obama’s American Jobs Act would raise economic demand and boost employment, while Republicans’ Jobs Through Growth Act would do little except protect corporate profits.” The Obama program, which is comprised of infrastructure spending, temporary payroll tax cuts, and extended unemployment coverage, would create 1.3 million jobs in the first year and raise GDP growth by 1.25 percentage points. By contrast, the GOP plan protects corporate profits by cutting the corporate tax rate, attacks unions, and repeals important financial regulations.

Rick Perry, Herman Cain, and Mitt Romney have all advocated for a regressive “flat tax” scheme that would tax everyone under the same rate. A simple flat tax might sound good on its face, but the details of such plans uncover a bad tax plan that hurts the middle class. I<any will see their net tax rates rise under the Republican plans. Both Cain and Perry’s plans also pose the potential problem of a shortfall in tax revenue. Even with their tax increase on the middle class, their flat taxes would bring in less revenue the Las Vegas Sun reports.

A Washington Post editorial calls GOP Presidential hopeful Rick Perry’s “flat tax” scheme, “less simple or fair” while leading to greater deficits. Read more about it in today’s Washington Post.

Hitting rock bottom: Alabama is also now requiring “proof of U.S. citizenship” before issuing library cards, ThinkProgress reports. Alabama’s new draconian anti-immigrant law also makes it a crime for undocumented immigrants to have water in their homes, ThinkProgress reports.

Bad news for “nativists” and know-nothings: A New York Times editorial points out the obvious, that the U.S. economy can’t work without immigrants. Read more at the New York Times.

Chart of the Day: As he so often is when it comes to budgets and basic economics, Republican darling Congressman Paul Ryan is wrong about Americans being upwardly mobile, TPM reports.

President Obama: “We Can’t Wait”

President Barack Obama has launched a national effort to urge Congress to pass the American Jobs Act, piece by piece, to put folks back to work and strengthen the economy.  Using the mantra “we can’t wait,” the President will highlight executive actions that his Administration will take.  He’ll continue to pressure Congressional Republicans to put country before party and pass the American Jobs Act, but he believes we cannot wait, so he will act where they won’t.

While in Las Vegas, Nevada the last week of October, the President highlighted a set of steps announced by the FHFA to make it easier for some homeowners to refinance their mortgages.  This will help responsible borrowers with little or no equity in their homes take advantage of today’s low mortgage rates.

The Administration also announced measures to help students better manage their student loan debt when they graduate.

These announcements will build on our ongoing effort to take action and help middle class families. For example, we decided to stop waiting for Congress to fix No Child Left Behind, and decided to give states the flexibility they need to help our children meet higher standards.  And the President acted to dramatically reduce the time it takes for small businesses to get paid when they have a contract with the federal government, and eliminated regulations that will save hospitals and patients billions of dollars.

These steps aren’t a substitute for the bold action we need to create jobs and grow the economy, but they’ll make a difference.  The fact is, our problems are too serious to simply do nothing.  The stakes are too high.  The issues facing Americans require serious bipartisan solutions, yet the Republicans in Congress have decided to put party before country and block legislation that would create jobs and grow the economy.  They blocked the Americans Jobs Act, a bill that independent experts said could create up to 2 million jobs.  And again, just last week, Senate Republicans obstructed a piece of the American Jobs Act that would keep hundreds of thousands of firefighters on the job, police officers on the streets, and teachers in the classroom when our kids need them most.

While President Obama continues to take executive actions, Republicans in Congress will have the opportunity to do what’s right for the country.  They’ll have a chance to vote on another piece of the Americans Jobs Act.  It’s a bill that will make an immediate investment of $50 billion in our nation’s surface transportation infrastructure and a $10 billion investment to create a bipartisan National Infrastructure bank.  Together, these initiatives will put hundreds of thousands of construction workers back on the job rebuilding our roads, rails, and runways.

We’ll continue to do our job.  Over the weeks and months ahead, we’ll continue to take actions that will improve the economy and help middle class families.  Now, it’s time for Republicans in Congress to do theirs. It’s time to put country before party and do what’s right for the American people.