It is safe to say that the Generic Drug User Fee Act would look very different—and may not have happened at all—without Mylan. And now it is safe to assume that the House Energy & Commerce/Oversight Subcommittee will do everything it can to make sure that FDA’s implementation of GDUFA aligns with Mylan’s vision for the new program.

At the very least, the newly named subcommittee chair, Rep. Tim Murphy (R-Pa.), will have to take Mylan’s calls. That’s because Murphy’s 16^th district, outside the Pittsburgh area, includes Mylan’s corporate headquarters. So if Mylan has an issue, it won’t just be another FDA stakeholder seeking Murphy’s attention – it will be a constituent.

That is in many ways appropriate.

Rep. Tim Murphy

Mylan played a key role in shaping the compromise that ultimately led to enactment of a program to apportion fees among the many different players in the generic drug space at a level that they could accept, but that would still provide meaningful resources to FDA. The compromise assures that generic drug reviews will soon be more timely and predictable, ending the second-tier status of generics in the ruthless chase for resources within the Center for Drug Evaluation & Research. Also see "Getting Organized for GDUFA: FDA Elevates Generic Review Activities Under New Director Geba" - Pink Sheet, 10 September, 2012.

That is no simple formula: FDA has wanted generic drug user fees for two decades, but industry could never get behind a proposal. The final push that led to legislation began with the generic industry trade association falling apart, and it was Mylan’s proposal that helped pull it back together.

That back story explains why Murphy was one of the five original sponsors of GDUFA in the house. Three Democrats sponsored the bill, including Energy & Commerce Committee Ranking Democrat Henry Waxman (D-Calif.), Health Subcommittee Chairman Frank Pallone (N.J.) and John Dingell (Mich.). It is impossible to imagine a bipartisan FDA bill without the support of those three members. The other Republican was Health Subcommittee Chair Joe Pitts (Pa.) – obviously the key starting point for the bill. But Murphy, as vice chair of the Subcommittee on Environment & Economy, was the outlier – except for the pivotal role Mylan played in the bill.

Oversight Subcommittee Has Long History With Generic Drugs

And now Murphy will have the key role in overseeing the implementation process, at least if he chooses to use the Oversight Subcommittee in the grand tradition started by Dingell decades ago. It was Dingell who chaired the hearings on the generic drug scandal of the late 1980s – hearings where, ironically, it was Mylan that played a “whistleblower” role, first leveling the accusations that ultimately revealed instances of bribery of FDA officials and fraudulent applications.

About Tim Murphy

Born: September 11, 1952

Education: BS, Wheeling Jesuit University (1974)

MA, Cleveland State University (1976)

PhD, University of Pittsburgh (1979)

Before Congress: Murphy served as a practicing psychologist and assistant professor at the University of Pittsburgh, as well as a Lt. Commander in the US Navy Reserve Medical Service Corps. He was elected to the Pennsylvania Senate in 1996. In the state Senate, he cosponsored a patient’s bill of rights.

First elected: November 2002; now in his fifth term, he won re-election November 6 with 64% of the vote.

That was many years ago, but the key emphasis of those hearings is relevant to 2012: with the Waxman/Hatch law of 1984, FDA felt pressure to get generic drugs out the door quickly, and the emphasis on rapid approvals meant minimal oversight of quality and integrity.

In 2012, there are similar dynamics at play. For many in the generic drug industry, the appeal of GDUFA is simple: FDA has an overwhelming backlog of applications, and average review times have crept above 30 months. User fees should help FDA get the trains running on time.

That, in fact, will be one important legacy of GDUFA.

But, at least for Mylan, that is not the only goal of GDUFA, or even necessarily the most important. Instead, Mylan emphasizes see GDUFA as first and foremost an inspection bill, providing sufficient resources for FDA to assure that all manufacturers face an equal compliance burden, no matter where they are located. In the user fee agreement, the language is “parity” for international inspections versus national.

GDUFA As Inspection Bill

Here is how Mylan CEO Heather Bresch described the law during the company’s second quarter earnings call.

“Mylan has long been a passionate leader and an advocate for many pieces of the legislation, which updates the 1938 law governing FDA to help protect the health and safety of consumers by requiring that all facilities that supply product in the U.S., regardless of where they're located, be routinely inspected by the agency and have the one quality standard. Through the landmark Generic Drug User Fee program, the new law also will help expedite approvals of generic drugs by reducing review times of ANDA from 31 months to 10 months over the next 5 years.”

Note the order: the first thing the law does is assure “one quality standard”; the second is to accelerate review times.

That is how Murphy sees the bill too. In a press release hailing House passage of the bill, Murphy does mention the impact on review times first, but places greater emphasis on the inspection piece.

“Murphy’s legislation…clears a backlog of 2,800 generic applications awaiting FDA review and factory inspection. His bill will provide the resources needed for the agency to approve generic medications in a timely manner. The bill also addresses a major safety gap in the global drug supply chain illustrated by the 2007 contaminated heparin outbreak. A Government Accountability Office study found the FDA had not inspected the Chinese plant responsible for producing counterfeit heparin, which killed nearly 200 people, and was only visiting foreign facilities on average once every nine years.

The Murphy bill moves the FDA toward inspecting foreign factories with the same rigor and biennial frequency that it does with domestic plants.”

In his remarks on being named subcommittee chair, Murphy doesn’t mention generics or FDA, but does stress his focus on “American manufacturing” more generally.

FDA certainly understands the dual goals of GDUFA—faster reviews and a greater emphasis on foreign inspections. And the agency also greatly wants and welcomes the resources to inspect overseas.

But with Murphy’s ascension to the top spot on Oversight, FDA is likely to be called to account more for its implementation of “parity” in foreign inspections than for its progress on review times – and for assuring that “parity” means “the same rigor and frequency” of inspections, not some other metric.

There is also a readymade subject for Oversight review if Murphy so chooses: Ranbaxy’s Thanksgiving recall of several lots of generic atorvastatin due to potential contamination with glass particles.

[Sidebar#2012500153]

Blackburn To Vice Chair; Compounding Crisis Takes Back Seat in House?

The selection of Murphy is also telling for who was not picked: Tennessee Rep. Marsha Blackburn will have to settle for the Vice Chair slot on the full committee, despite making a push for the gavel at Oversight.

Another contender for the Oversight Committee, Nebraska’s Lee Terry, will instead chair the Commerce, Manufacturing & Trade Subcommittee, formerly chaired by Rep. Mary Bono Mack (California), who was defeated on November 6.

Murphy’s Reform Plans

Here are five “specific ideas” to improve quality and reduce costs, listed by new Energy & Commerce Committee/Oversight Subcommittee Chair Tim Murphy:

Fix Federally-Funded Care First, by creating a “quality reform commission” to identify and fix the inefficiencies in Medicare and Medicaid. He cites the SMART Act as an example of the inefficiencies that could be targeted.
Promote Evidence-Based Medicine; he cites New England Health Institute data arguing that variation in the intensity of medical services drives up to $600 billion in waste, and that “misuse of drugs and treatments” causes preventable adverse events costing $52.2 billion.
Chronic Care Management, to encourage coordinated care for chronic conditions, rather than payment for “every poke, prod, pinch or prescription.”
Quality and Transparency, meaning posting information about health outcomes for public review and comparison.
Use Health Centers for Primary Care Access, emphasizing the “workforce shortage” that limits staffing of community health centers, with solutions including a proposal to provide liability protections for medical staff.

Blackburn would likely have placed a significant emphasis on FDA’s response to the meningitis outbreak associated with a compounded injectable steroid. Tennessee has been one of the states hardest hit. More than 80 cases of fungal meningitis have been reported in Tennessee, including 13 deaths (the most in any state), according to the Centers for Disease Control & Prevention.

Not that FDA will get a free pass on the meningitis response in the next Congress: the state with the most meningitis cases (178 as of November 26) is Michigan, the home state of E&C Committee Chair Fred Upton. Tennessee’s concerns will also be heard, both via Blackburn’s consolation prize role as Vice Chair of the full committee, but also via the new position for Sen. Lamar Alexander as Ranking Republican on the Senate Health Committee.

Still, the presence of manufacturing interests in the districts of Murphy and Upton (Pfizer and Perrigo are local employers) may help assure that the continued investigation into compounding authorities does not become overly disruptive for other key FDA operations.

Murphy is also likely to take an interest in the pricing issues that, some in industry would argue, cut across both the compounding issue and the larger problem of drug shortages. Murphy has spoken up on the side of addressing reimbursement policies that he believes pose a barrier for manufacturers seeking to supply products that are in high demand and/or tight supply. ([A#2012500115])

Of course, Murphy’s Oversight agenda won’t be limited to generic drug and supply chain issues, or even to broader manufacturing/job creation topics.

Murphy is a psychologist and is co-chair of the Mental Health Caucus and the GOP Doctors Caucus. That has given him a platform to push for mental health parity legislation and address broader issues of health care affordability. As a Lt. Commander in the Navy Reserve Medical Service Corps, Murphy also works at Walter Reed to help veterans with traumatic brain injury and post-traumatic stress disorder.

Not surprisingly for someone given a GOP leadership role, Murphy has called for the full repeal of the Affordable Care Act.

However, he has also shown a willingness to work on incremental legislation to improve the health system without demanding a complete repeal of ACA. He was a primary sponsor of the SMART Act (HR 1063), which is intended to simplify the process for collections from Medicare Secondary Payers who make recoveries from providers or beneficiaries. The legislation has more than 100 additional sponsors in the House, including many Democratic co-sponsors, and companion legislation is sponsored by Ron Wyden (D-Ore.) in the Senate.

GDUFA Implementation Will Be Overseen By Mylan’s Representative in the House

More from Legislation

More from Pink Sheet