Flickr photo by watchingfrogsboil

After advancing the 21st Century Cures Act – which, contrary to the hype, would put patients at risk – the McConnell-Boehner Corporate Congress next week will grill the White House official in charge of our system of safeguards. It is one of several public interest attacks that we are tracking:

• Howard Shelanski, administrator of the Office of Information and Regulatory Affairs (OIRA), will be on the hot seat not once but twice next week. OIRA is part of the White House Office of Management and Budget, where every proposed regulation must go before it is finalized. Shelanski oversees the regulatory review process. We’re talking about the rules that keep our water safe to drink, our food safe to eat, our air safe to breathe, our workplaces safe and much more.

Shelanski is scheduled to testify at a 3 p.m. oversight hearing on Wednesday, July 15, before the U.S. Senate Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law, and then at 2 p.m. Thursday, July 16, before the Senate Committee on Homeland Security and Governmental Affairs’ Subcommittee on Regulatory Affairs and Federal Management. Expect lawmakers to grill him on fabricated claims of overregulation. In fact, underregulation is the norm because of constant industry pressure and conservative ideological opposition to even the most commonsense standards. Even when agencies do regulate, the public often must wait years and sometimes decades before being protected by new safeguards.

• Lawmakers are pushing to expedite the export of liquefied natural gas, despite the fact that doing so would harm consumers (see S. 33, the LNG Permitting Certainty and Transparency Act, for instance). At 2:30 p.m. on Tuesday, July 14, the Senate Committee on Small Business and Entrepreneurship will hold a hearing about “challenges and opportunities” for small businesses engaged in energy development and manufacturing. Tyson Slocum, director of Public Citizen’s Energy Program, will testify, focusing on how limiting exports will keep prices lower for small businesses and household consumers.

• The Senate Finance Committee next week may take up a tax giveaway package that is of concern to public interest advocates. Public Citizen is focused on two handouts dealing with international tax issues, the “active financing” and “CFC look-through” extenders. See more information here and here.

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yPzzc31-Statement of Vijay Das, Health Care Policy Advocate, Public Citizen’s Congress Watch Division

Note: Today, the U.S. House of Representatives overwhelmingly voted in favor of H.R. 6, the 21st Century Cures Act.

It is disappointing that the House has passed the 21st Century Cures Act. The bill is a bad deal for patients. It fails to advance scientific innovation and medical breakthroughs, and would undermine our ability to approve safe and effective medications as well as high-risk medical devices.

At its core, this legislation is a horse trade: In exchange for increased funding for the world-renowned National Institutes of Health (NIH), lawmakers added perks for the pharmaceutical and medical device industries. This is unacceptable.

We should not hold NIH funding hostage in the false pursuit of scientific and medical breakthroughs while undermining safety and access to essential medicines and treatments.

The bill lowers standards for U.S. Food and Drug Administration (FDA) approval of medical devices and medications (particularly with respect to antibiotics), scales back the requirements of the Physician Payment Sunshine Act and extends marketing exclusivity for certain pharmaceutical treatments, which would drive up health care costs while making it more difficult for ordinary people to access affordable treatments.

Several proposed amendments would have mitigated some of the damage caused by this bill, but the House Rules Committee did not permit a vote on them.

One rejected amendment (PDF) would have eliminated a provision that undermines medical device safety. Another rejected amendment (PDF) would have limited the coddling of the pharmaceutical industry by striking a provision that extends the time patients must wait for generic versions of medicines to enter the market.

As written, this medication marketing provision would delay patients’ access to affordable, life-saving medicines. The Congressional Budget Office estimates (PDF) that this six-month extension of marketing exclusivity for certain pharmaceutical products would cost the federal government about $869 million between 2016 and 2025. This provision adds costs to the federal budget that would increase over time.

The Senate should not take up this bill, but should instead craft an alternative that restores federal investments in basic science and research while upholding standards to ensure safe and effective treatments are approved for patient use.

The White House issued a statement (PDF) that made mention of our concerns regarding this sweeping deregulatory bill. The president should do more.

The president’s best course of action is to veto the 21st Century Cures Act should it make its way through Congress.

fda approved smallNo one can dispute that multidrug-resistant “superbugs” are a key public health concern for the 21st century. Better, safe and effective cures are needed. But the 21st Century Cures Act, legislation that will be voted on this week in the House, is not the solution to this problem.

Over 2 million people are infected with antibiotic-resistant bacteria each year, resulting in at least 23,000 deaths. New antibiotics have been slow in coming: No antibiotic with a truly novel mechanism of action has been discovered since the late 1980s. Yet this drought is not the fault of the Food and Drug Administration (FDA), which has long been under tremendous pressure to approve new antibiotics quickly. This pressure was increased even further by a 2012 law that accelerated review for qualifying antibiotics.

Thanks to the current review process for antibiotics, clinical development for these drugs is already quick by industry standards. A new antibiotic takes only seven years to get to market, compared with nine years for cancer drugs.

Quick approval is not without costs. Many of the antibiotics approved over the past decade have suffered from safety and effectiveness problems. For example, tigecycline (Tygacil), an antibiotic that received special accelerated FDA approval in 2005, was slapped with a black-box warning in 2013 stating that the drug increases the risk of death.

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by Nicole Arbabzadeh

A recent article by David Lazarus in the Los Angeles Times delivers a harrowing glimpse into the Fairness in Class Action Litigation Act (H.R. 1927) and its potentially devastating ramifications to the justice system should it pass in Congress. If class action lawsuits are already becoming endangered due to the systematic use of forced arbitration, H.R. 1927 would ultimately guarantee total extinction.

The disingenuously titled bill, endorsed by the U.S. Chamber of Commerce and sponsored by U.S. Reps. Bob Goodlatte (R-Va.) and Trent Franks (R-Ariz.), would effectively eradicate class action lawsuits due to its sweeping measures and preposterous restrictions. Franks has unabashedly lauded the measure as a means to “allow those with serious injuries to have their own day in court.”

The truth is radically different.

In reality, the bill prohibits individuals with serious injuries or lesser grievances from accessing the legal system at all. Under the current system, class actions may be brought if class members experience similar injuries or complaints. If this bill passes those types of class actions will move forward only if “each proposed class member suffered an injury of the same type and scope as the injury of the named class representative or representatives” (emphasis added) – a nearly impossible standard to meet — hence the extinction.

Under the “same type and scope” stipulation, the following claims would be precluded from joining a class action suit:

• Any claim that is off by even a margin of $1 (all claims, for example, in a securities fraud case, would have to exactly match that of the class representative).

• Any claim that does not involve the same injury to the same body part (all physical injuries, for example, in a cars’ faulty brakes case, would have to pertain to a broken leg, not a broken arm or other ailment pertaining to the leg).

With such arbitrary and absurd demands, even the most historically important class action lawsuits would have been prohibited from proceeding.

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By Andrew Gibson

This Saturday, our nation celebrates the 239th anniversary of the signing of the Declaration of Independence. This day should be used to reflect on the ideals and principles upon which this country was founded so as to remind us of the work still to be done in order to achieve goals enshrined in that all-important document.

The Declaration of Independence affirms America’s self-governance. It states that “governments […] derive[e] their just powers from the consent of the governed,” and that all are treated equal under the law. As Public Citizen strives to ensure that all citizens are represented in the halls of power, our members and supporters should keep the founders’ philosophy in mind as we celebrate America’s birthday with our family and friends.

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