Posted 20 January 2015
By Alexander Gaffney, RAC
For months, legislators on the House Energy and Commerce (E&C) Committee have been working with a large group of stakeholders in the hopes of developing a series of reforms to the way the US Food and Drug Administration (FDA) approves new drugs and medical devices.
Now the committee has reached out in the hopes of recruiting one especially important stakeholder to its cause: President Barack Obama.
The legislative effort, known at the 21st Century Cures Initiative—or #Path2Cures, if Twitter hashtags are your thing—kicked off in May 2014, and is being spearheaded by Reps. Fred Upton (R-MI) and Diana DeGette (D-CO).
The effort is being billed as a fundamental reassessment of the entire way medical products are regulated in the US, with an emphasis on getting new cures and treatments to the neediest patients even faster. Already, legislators have held roundtables on clinical trials, digital health, the perspective of patients, personalized medicines, lab-developed tests, antibiotic resistance and communicating medical advancements.
A flurry of new legislation introduced by some legislators involved in the effort, captured in Regulatory Focus’ FDA Legislation Tracker, has also previewed some of the legislative language likely to be included in the coming legislative draft, which is due to be released by the end of January 2015.
E&C to Obama: Join Us
And now, with Obama set to give his annual State of the Union address on 20 January 2015, Rep. Upton has reached out in the hopes of recruiting Obama's support for the coming measure.
"As we look toward this new year and new Congress, I am encouraged by the bipartisan achievements we have already made throughout the 21st Century Cures initiative and grateful for the support of top administration officials,” Upton wrote in a press statement. “I hope that President Obama will consider joining our effort to boost jobs, ensuring the United States remains the epicenter of innovation, and help bridge the gap between the incredible advances made in science and how we in Washington actually regulate those therapies."
"There is no issue more important to families all across the country," he added.
Obama Usually Silent on FDA
Obama, however, has been relatively silent on matters of FDA regulation throughout his presidency. Despite signing into law several major pieces of legislation related to FDA regulation—the Patient Protection and Affordable Care Act (PPACA), the FDA Safety and Innovation Act (FDASIA) and the Drug Quality and Security Act (DQSA) among them—Obama has said almost nothing publicly about his views on drug or device regulation. For example, Obama offered no signing statements on either FDASIA or the DQSA despite both attracting overwhelming bipartisan support.
There are, however, exceptions to Obama's silence.
In 2011, with the presidential election just months away, the Obama administration reversed FDA's approval of an over-the-counter version of Plan B which could be sold to women over the age of 14.
"The reason Kathleen [Sebelius] made this decision is that she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able—alongside bubble gum or batteries—to buy a medication that potentially, if not used properly, could have an adverse effect," Obama said in remarks to the White House press pool.
"[Sebelius'] judgment was that there was not enough evidence that this potentially could be used improperly in a way that had adverse health effects on those young people," Obama added, noting his support for her decision.
The administration later reversed its decision following a lengthy court battle, but the decision has gone down in history as the first time an FDA decision has ever been overturned by the Executive Office.
Biologics Battle as a Precursor
Other efforts by Obama to make reforms to FDA have been more indirect and quiet in comparison to the Plan B decision.
Obama's administration has repeatedly come out in favor of lowering the amount of time approved biologics are given marketing exclusivity by FDA. The PPACA contained then-controversial provisions granting biologics 12 years of patent protection from competition. Administration officials have frequently argued they should instead be given 7 years of protection—two more than is currently standard for new chemical drugs. Some legislative proposals—notably the Dormant Therapies Act—have expressed support for 15 years of marketing exclusivity for many new drugs. If included in the E&C legislative draft, the legislation might get a cold reception at a White House already loath to support 12 years for even more complex drug products.
Obama might also find himself torn between supporting agency officials at FDA and the 21st Century Cures effort. Two regulatory proposals advanced by FDA regarding generic drug labeling and lab-developed tests have come under fire from House Republican legislators, and efforts to neuter both might well be included in the E&C Committee's legislation.
Another potential issue is the bill's effect on the federal budget. Legislators have made clear they hope to make it easier for drugs intended for small patient populations to come to market. While that could be good news for drug companies and patients alike, it could be bad for the federal budget. Many drugs marketed toward smaller populations are often incredibly expensive, forcing insurers or federal payers like Medicaid and Medicare to pick up the tab for patients. An influx of new and expensive drugs might prove to be a strain on both the federal budget and the fiscal solvency of federal programs.
For legislators, then, Obama's support for their effort might well be forthcoming, but probably won't be overwhelming.
E&C Letter to Obama
21st Century Cures Page