Democratic, Republican Political Platforms Contrast Approaches to FDA Regulation

Posted 04 September 2012 By Alexander Gaffney

Political platforms put forth at both the Republican and Democratic national conventions address the US' regulatory structure, including regulations promulgated by the US Food and Drug Administration (FDA).

The platforms are broad, consensus-based documents aimed at providing a general statement of principles by which each respective party stands. Though they are not binding upon any candidate who wishes to affiliate with the party, the statements can be a harbinger of policies to come.

GOP Platform: Reform FDA

The Republican party, which met for its national convention in Tampa, FL on 27-30 August 2012, unveiled its party platform in a document entitled, "2012: We Believe in America."

The document contains an entire section dedicated to what it called "Reforming the FDA."

"America's leadership in life sciences R&D and medical innovation is being threatened," Republicans claim. "As a country, we must work together now or lose our leadership position in medical innovation, US job creation, and access to life-saving treatments for US patients."

Despite this decades-long position as a leader in the life sciences industry, a "lack of predictability, consistency, transparency and efficiency at the Food and Drug Administration [is] driving innovation overseas," wrote Republicans.

"We pledge to reform the FDA so we can ensure that the U.S. remains the world leader in medical innovation, that device and drug jobs stay in the US, that U.S. patients benefit first from new devices and drugs, and that the FDA no longer wastes US taxpayer and innovators' resources because of bureaucratic red tape and legal uncertainty," they conclude.

In a separate section of the platform, Republicans lambaste FDA's approval of Mifeprex (RU-486), often used as an abortifacient drug, and call for increased access to stem cell research using non-embryonic stem cells.

Republicans Call for Less Regulation

The Republican platform also calls for reduced amounts of regulation, arguing that reducing it "encourages business formation and job creation."

"Government spending and regulation must be reined in," it states. "We call on the federal government to do a systematic analysis of laws and regulations to eliminate costly bureaucratic mandates on the States and the people," it continues in a later section.

In yet another section subtitled, "Regulatory Reform: The Key to Economic Growth," the GOP claims "over-regulation" amounts to a "stealth tax" on consumers to the tune of $1.75 trillion per year.

"Many regulations are necessary," it concedes, "like those which ensure the safety of food and medicines, especially from overseas." But at the same time, the GOP said it is in favor of automatically sun-setting older regulations and requiring agencies to revisit them, and also said it would favor mandatory congressional review for high-impact regulations.

But perhaps most important of all is its support of a "moratorium" on all "new major and costly" regulations until the president-in its reading, the "Republican Administration"-reviews all existing rules for cost effectiveness and a "sound basis in science."

Democrats: Regulations Should be Based on Sound Science

Democrats, who unveiled their own party platform at their Charlotte, NC political convention on 4 September 2012, largely avoided talking about FDA. Though they called attention to the fact that women will be able to access FDA-approved contraception under the Patient Protection and Affordable Care Act, Democrats tended to talk about regulation in broad terms.

"Rules should be simpler and more flexible, and regulations should be based on sound science and secure Americans' freedom of choice," Democrats wrote in their platform, entitled, "Moving America Forward."

"A 21st century regulatory system must promote economic growth, innovation, and job creation while also protecting public health and welfare," they continued, pointing to the "cost-effective approach" championed by President Barack Obama's regulatory czar, Cass Sunstein. The platform also calls attention to Obama's regulatory record, which Democrats claim created fewer regulations than did President George W. Bush in his first term.

"President Obama has also called for an ambitious, transparent, and unprecedented government-wide review of existing federal regulations to eliminate unnecessary rules," explained the Democrats. "In response, more than two dozen agencies have released plans to streamline existing requirements."

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