Medical Devices

Unseemly and Inappropriate: FDA Joined With the Medical Device Industry in Drafting Cures Legislation

, ,

Dr. Michael CaromeStatement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, Inside Health Policy reported that senior officials at the U.S. Food and Drug Administration collaborated with representatives from the medical device industry on the wording of the 21st Century Cures bill, passed by the U.S. House of Representatives in July. What’s more, the FDA and industry are strategizing together about how to get a companion bill through the Senate. The bill would weaken oversight of medical devices and is opposed by Public Citizen and other consumer and patient advocacy groups. Dr. Robert Califf, nominee to head the FDA, participated in at least one high-level strategy meeting with the industry regarding these efforts.

It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices.

No one from the FDA should ever have been involved in such a process, which violates the most elementary ethical standards. The last person who should have been collaborating with the industry over policy proposals is the person in line to run the agency. Yet Dr. Robert Califf, the current nominee to serve as FDA commissioner, did exactly that.

In response to this outrageous news, the U.S. Senate should, at minimum, halt consideration of Dr. Califf’s nomination until it has an opportunity to investigate fully exactly what occurred. We believe that news of Dr. Califf’s participation in this collusion with industry provides still further evidence that his nomination should be rejected. The attitudes he has developed over his decades-long history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety. This is not compatible with being the FDA commissioner.

THIS WEEK: Derivatives, resolutions, Internet freedom of speech and the 2012 Corporate Power Tool Award

, , , , , , , , ,

This week, we’ve got our eyes on Congress, Wall Street, the “#1 Corporate Power Tool,” school districts and more!"Public Citizen Lady Liberty"

For better or worse, Washington D.C. is a city of awash with acronyms. And this week, there are a few capital letters that the medical device industry would rather you not pay any attention to: MDUFA. Literally, MDUFA stands for Medical Device User Fee and Modernization Act, but in actuality these letters simply mean danger for consumers.  A lot of the coverage of MDUFA has focused on the prescription drug aspect. However, the story is about more than drugs. Medical device safety is at a crossroads, and Congress could really mess things up. Here is where MDUFA stands now.  We recently wrote a report, which documented the average number of high-risk recalls of medical devices in 2011 was more than double than in recent years. We also documented the keen interest the medical device industry seemed to have in weakening already lax regulations. This week Congress will vote on MDUFA and we urge them to put patient safety ahead of corporate profit.

Today, amid the news coverage of JPMorgan Chase’s $2 billion loss in derivatives bets, Public Citizen published a report, many weeks in the making, that expounds on the historical lessons of derivatives deregulation and the urgency to implement the rules called for in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. Read a copy of the press release which links to the report entitled: “Forgotten Lessons of Deregulation: Rolling Back Dodd-Frank’s Derivatives Rules Would Repeat a Mistake that Led to the Financial Crisis.” The report explains how America’s top financial policymakers deregulated the financial derivatives market in the 1990s and provides a detailed account of how deregulation led to the ensuing housing bubble, financial crisis and Great Recession.

The report comes as members of Congress have introduced nine bills that would weaken the derivatives provisions of the Dodd–Frank Wall Street Reform and Consumer Protection Act of 2010.

All seven bills moving in the U.S. House of Representatives have been approved by committees, and three have passed the full House. Two bills that would exempt overseas transactions from Dodd-Frank’s derivatives provisions may be voted on as soon as Thursday in the House Agriculture Committee. Other bills would exempt trades by supposedly “small” players, reduce transparency requirements and strike down a provision to ban derivatives trading by federally insured banks. At least three other bills would impose impediments for agencies to promulgate rules concerning financial services in general.
More

THIS WEEK: Medical devices, scary poultry, trade, the Freeze Act & stand-up comedy?!

, , , , , , ,

We are, literally, throughout the world this week (though we plan to call it a wrap with some laughs in Los Angeles this weekend). “Laughs?” you say? We know. We are policy nerds. How could we possibly be funny?! The answer is: We can’t. Luckily though, we have some ALL-STAR comedians to help us out. But more on that later!

Right now, let’s refocus on Melinda St. Louis of Public Citizen’s Global Trade Watch. Melinda is currently participating in the 13th Quadrennial Conference of the United Nations Conference on Trade and Development in Doha, Qatar. There, St. Louis will be featured on a panel ce"Public Citizen Lady Liberty"ntered on state’s rights. Trade agreements should not undermine trading countries own laws. For example, the U.S. should have the right to pass laws banning clove cigarettes that pose significant health threats and are disproportionately targeting American youth, undermining years of work on curbing teen smoking.

In addition to this, Public Citizen is also sponsoring two symposia at Doha. The title of the first, “Safeguarding development and the public interest from investment provisions in trade and investment agreements,” had this Lady Liberty rushing to find a translation. Turns out, this symposium is focused on investor-state clauses, (shorter but still unclear, right?). Take two: Investor-state clauses in trade deals are troubling aspects of trade pacts that essentially give corporations special rights and their own private judicial system. These “investment provisions” are used by companies to sue governments and challenge all sorts of regulations from environmental, to health and even financial regulations  … and that brings us to symposium No. two: “Safeguarding stability: Ensuring coherence between financial re-regulation and global trade rules.” In essence, you know all the Wall Street reform legislation that was enacted by Congress? Well, it appears that U.S. Rep. Darrell Issa (R-Calif.) may not be the only barrier we may run into in getting these reforms enacted and working so that we can protect ourselves from the next economic crash. Gretchen Morgenson of the The New York Times writes of the sad reality that Public Citizen’s Lori Wallach has been ringing an alarm about for some time: “According to the W.T.O., 125 of its 153 member countries have made varying degrees of commitments to the financial services agreement. Now, these pledges could easily be used to undermine new rules intended to make financial systems safer.” For more on this issue please see this portal.

Today, Public Citizen sent a letter to lawmakers on Capitol Hill, urging lawmakers to pass the “Democracy Is Strengthened by Casting Light on Spending in Elections” or DISCLOSE Act. The letter was signed by several dozen groups, ranging from campaign finance reform advocates, and transparency organizations to business ethics and investor groups. The need for disclosure of campaign expenditures is more important than ever following the 2010 U.S. Supreme Court Citizens United v. Federal Election Commission (FEC) ruling that opened the floodgates to unlimited corporate spending to influence elections. When it comes to campaign finance law, the cardinal rule is that citizens are entitled to know the names of donors who are financing campaigns and trying to influence their votes, and the amounts they give. We are pushing for disclosure both on a legislative level and through the unique work of the Corporate Reform Coalition, which has put a spotlight on the role the Securities and Exchange Commission, as the protectors of shareholder interests, ought to be playing in forcing corporations to disclose their political spending.

Of course, the other half of this story is stopping this outrageous spending! With major victories last week both on Capitol Hill and in the state of Vermont, Public Citizen’s Democracy Is For People campaign is plowing forward on the fight for a constitutional amendment to overturn the Citizens United ruling and get our elections and democracy taken off the auction block. In this week’s California Progress Report, Jonah Minkoff-Zern, senior organizer with our Democracy Is For People campaign writes, “Vermont Was Third. Will California Be Next?” Thanks to Jonah’s work alongside Public Citizen activists and allies the answer is likely, yes! Stay tuned to CitizenVox for more in the coming weeks on California.
More

Money and Democracy Update: Supreme Court showdown

, , , ,

"Public Citizen Money and Democracy"Stunning Statistics of the Week:

$5.2 million: Amount President Barack Obama’s campaign spent last year for Internet advertising
$9.5 million: Amount Obama’s campaign spent on telemarketing
$2.6 million: Amount GOP contender Newt Gingrich spent on telemarketing
$1.3 million: Amount Obama’s campaign spent on credit card fees for donations
$143,862: Amount Obama’s campaign spent last year on text messages

New Mexico Legislature approved amendment resolution
New Mexico’s Legislature has passed a resolution calling on Congress to pass a constitutional amendment to overturn Citizens United v. Federal Election Commission, the U.S. Supreme Court ruling that said corporations can spend unlimited amounts of money to influence elections. New Mexico is now the second state to pass such a resolution (Hawaii was the first).

 

Supreme Court showdown
Corporations challenging the Montana Supreme Court’s decision upholding the state’s restrictions on corporate political expenditures have asked the U.S. Supreme Court to put the law on hold pending a decision on whether the Supremes will hear the case. Montana’s Attorney General has responded that the challengers are asking the court “to invalidate Montana’s Corrupt Practices Act – an Act that has safeguarded the republican form of government in Montana for a century from the scourge of political corruption.” The challengers’ request will be considered by Justice Anthony Kennedy and may be referred to the full court for decision.

More

Big Pharma & medical device industry are anxious to ride the deregulatory wave

, , , ,

Bad news. The dangerous anti-regulation campaign sweeping Congress has hit the Food and Drug Administration (FDA) – the agency tasked with ensuring the safety of our drugs and medical devices. Over the last two months, several members of Congress have introduced misguided bills that would make it easier for manufacturers to sell new, unsafe medical devices, and in turn put patients’ lives at risk.

"FDA drug approval"
FDA commissioner Margaret Hamburg (right) speaks with Public Citizen president Robert Weissman (left) at a Public Citizen event on July 25, 2011. Click on the photo above to view YouTube video of this event.

Evidently, some members of Congress are buying into the arguments from the medical device and pharmaceutical industries that the process to approve drugs and devices is too lengthy, blocking their products from the market, and depriving pharma and device companies of their precious profits. However, contrary to industry’s statements, the FDA recently reported that its approvals of new drugs have increased.

The industries’ predictable talking points come as they negotiate with the FDA and Congress over a process to reauthorize fees collected from the industry and reevaluate FDA rules and practices. The process is expected to be completed in 2012. Unfortunately, if these anti-safety initiatives gain traction the lives of patients will take a back seat in the negotiations.

The innovation and continued improvement of drugs and medical devices are important health care goals, but the FDA shouldn’t lose focus on ensuring their safety. Recent history shows that dangerous drugs and devices have unnecessarily injured or killed hundreds of thousands of patients, strongly indicating that industry profits trumped patient safety in numerous instances.
More

Load More