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FDA fast-tracking experimental drugs

The development of a pharmaceutical drug is a slow, deliberate process, and it can take years of back-and-forth between scientists and health officials before medicine makes it to the market.

But the worst Ebola outbreak in history has changed all that. The Food and Drug Administration is in crisis mode, and its process of reviewing applications for new drugs has been pushed into overdrive. The arrival of the deadly virus on American soil has created an unprecedented situation for the regulatory agency, especially when it comes to experimental drugs.

Now, FDA officials are reviewing new drug applications to fight Ebola in a matter of days instead of months or years. In August, two American health care workers who contracted Ebola in Liberia received an experimental drug called ZMapp in the U.S. and made a full recovery. The FDA also approved an antiviral drug called TKM-Ebola for use in "emergency cases" to fight the virus. Last week, Thomas Eric Duncan received brincidofovir, an antiviral drug originally developed to treat smallpox, after the FDA approved it for emergencies only. He died two days later.

Until this year, none of these drugs were approved for use, let alone deemed safe for humans, by the FDA.

In the U.S., when physicians ask the FDA for permission to use experimental drugs on their patients, as they have recently in Dallas, the agency responds in a matter of hours—and often, less than one hour.

FDA regulations prohibit the agency from disclosing information about experimental drugs, as well as how many doctors have asked for them. The agency has oversight over any experimental medicine administered to Ebola patients in the U.S.

The FDA has had to bend the rules in its review of applications for new drugs, too. Most of the drugs the FDA has approved for emergency use against Ebola have not even reached clinical trials yet.

House hearing on Ebola preparedness

On Thursday, the Energy and Commerce subcommittee on Oversight and Investigations, chaired by GOP Rep. Tim Murphy(R-PA), held a hearing on Ebola. In particular the hearing examined the preparedness of the United States ports, point of entry, healthcare facilities and other institutions to identify, diagnose, isolate, and treat Ebola patients in a safe and appropriate manner.

Heading the list of scheduled witnesses at the hearing Thursday were Centers for Disease Control and Prevention Director Thomas Frieden, and Daniel Varga, the chief clinical officer and senior vice president of Texas Health Resources. Also testifying were Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, and Luciana Borio, assistant commissioner for counterterrorism policy at the Food and Drug Administration, among others.

CDC Chief Frieden's appearance came a day after two Republican lawmakers, Reps. Tom Marino of Pennsylvania and Pete Sessions of Texas, called for his resignation. The agency has received criticism for its handling of the most recent case of Ebola in the United States, a nurse who treated Thomas Eric Duncan, a Liberian man who died of the disease shortly after he flew to Texas. CDC officials first said that health workers at the Dallas hospital where Duncan was treated violated federal safety guidelines. Then, news reports revealed that the nurse, Amber Vinson, took a commercial flight from Cleveland to Dallas while running a fever, and Frieden said that she "should not have been allowed to travel by plane."

During Thursday's hearing, lawmakers didn't miss this lapse in communication to the public about what really happened. "It would be an understatement to say that the response to the first U.S.-based patient with Ebola has been mismanaged, causing risk to scores of additional people," said Rep. Diana DeGette, D-Colo.

In his testimony, Frieden described the new steps the CDC was taking to combat the spread of Ebola in the U.S. including:

  • Providing increased training and education at the Dallas hospital
  • Recommending that the number of health care workers who treat Ebola patients be kept to a minimum and that contact be limited to only essential procedures
  • Recommending that someone be in charge of overseeing infection-control full-time while the patient is being treated
  • Issuing stricter guidelines for use and removal of protective gear.

Frieden said that from now on, "Ebola response teams" from the CDC will travel to any U.S. hospital with a confirmed Ebola case within hours to help supervise safety protocols.

Frieden and other top health officials remain opposed to a travel ban from affected countries into the U.S. In his testimony, he reiterated the argument that opponents of a ban are making - namely that these restrictions would impede aid efforts in West Africa and that it would make it more difficult to track those who end up making it into the U.S.

Click here to view the Washington Business Brief video, “LaTourette talks about the Mid-terms and the Lame Duck”

GM weighs in on net neutrality

Cell phone carriers got a surprising new ally this week in their fight against stricter net-neutrality laws: General Motors (GM). The car company sent a letter to the Federal Communications Commission earlier this month urging the agency not to impose tough rules on wireless Internet service. Treating wireless Internet the same as a home connection would stifle innovative new technologies, GM wrote.

"From our point of view, mobile broadband being delivered to a car moving 75 mph down a highway—or for that matter, stuck in a massive spontaneous traffic jam—is a fundamentally different phenomenon from a wired broadband connection to a consumer's home," wrote Harry Lightsey, the executive director of GM's Global Connected Consumer unit.

He said that car companies are increasingly relying on wireless networks to provide new technologies to their customers. High-speed cellular connections allow people to stream Internet radio and video in their cars, and some cars even have built-in Wi-Fi hotspots.

Companies are also starting to experiment with technologies that would allow cars to talk to each other to avoid collisions and monitor traffic patterns. Those technologies all rely on some form of wireless connection.

"By needlessly constraining the latitude our mobile network operator suppliers have in delivering connectivity to owners of our vehicles, you would also constrain the innovations we are seeking to provide to our customers," Lightsey wrote.

Net neutrality is the principle that Internet providers shouldn't be allowed to manipulate traffic or favor some services over others.

The FCC first enacted net-neutrality rules in 2010 that focused on home Internet service and largely exempted cellular connections. A federal court struck down those rules earlier this year, and FCC Chairman Tom Wheeler is now trying to craft new regulations that can survive future court challenges.

Wheeler has strongly hinted that he may scrap the distinction between wireless and fixed Internet, noting that an increasing number of people rely on their phones to access the Internet.

Verizon, AT&T, and the other cellular carriers argue that wireless Internet is different because it's difficult to transmit data over-the-air. They want more flexibility to prioritize some services, especially if a cell tower is congested.

Deficit falls to lowest level since 2007

Lost in the shuffle of the Ebola panic is some good economic news. This week, the White House announced that the deficit had fallen to its lowest level since 2007.

In trumpeting the news, the White House said:

Thanks to a growing economy, prudent spending cuts, and asking the wealthiest Americans to pay a little bit more on their taxes, we’ve cut our deficits by two-thirds over the last five years. In fact, the Office of Management and Budget and the Treasury Department announced today that the deficit has fallen to 2.8 percent of GDP, the lowest level since 2007 and less than the average of the last 40 years.

Obama to wait on Attorney General nominee

This week, sources in the White House confirmed that President Obama will wait until after the November mid-term elections to announce his choice to succeed Eric Holder as Attorney General.

Republicans have told the White House that nominating a new Attorney General during the lame duck would be unacceptable, but in reality there is little they can do to stop it.

Because Senate Majority Leader Harry Reid (D-NV) triggered the so-called "nuclear option" earlier this session, there will be no possibility of a GOP filibuster of Obama's pick. And all it will take to confirm his choice will be a simple majority vote. Given that Democrats, at least for the rest of the year, have 55 seats, the onus will be on the White House, Reid, and Senate Judiciary Committee Chairman Patrick Leahy to hold their caucus together rather than court Republicans. And that will become much easier without the threat of an election looming.

It is believed that former White House Counsel Kathryn Ruemmler has emerged as the leading candidate to replace Holder, though indications are that President Obama hasn’t settled on one candidate yet.

If nominated, Ruemmler would likely encounter tough questioning during her confirmation hearings about advice she gave President Obama during her time in the White House.

Other candidates being considered by the White House are believed to include U.S. Solicitor General Don Verrilli, Labor Secretary Tom Perez, and Loretta Lynch, the U.S. Attorney for the Eastern District of New York.

Transportation in focus

Short term transportation patches costing jobs

According to a new study by Duke University’s Center on Globalization, Governance and Competitiveness, the short-term patch approach that Congress has taken on funding the highway bill is costing America jobs. The study says the piecemeal approach, “costs the United States over 900,000 jobs – more than 97,000 in manufacturing – and makes the United States less competitive than its top trading partners.”

The study also shows that the lack of investment in infrastructure, “lead[s] to delays, congestion, and disruptions that affect everyone: citizens, consumers, manufacturers, buyers, sellers, importers and exporters.”

The study concluded that passing a long-term transportation bill of $114 billion annually would create upwards of 2.48 million American jobs.

Other findings of the study include:

  • Every dollar invested in transportation infrastructure returns $3.54 in economic impact.
  • Deficient and decaying infrastructure makes the United States less competitive than many of our top trading partners, with global assessments ranking the United States 16 out of 144 nations and 6 among our top 15 trading partners.
  • The U.S. invests on average $848 per person annually on transportation investments compared to the European Union’s $2,589 per person. This underinvestment has contributed to a $900 billion backlog in needed investments and repairs in the U.S.

Duke University’s CGGC partnered with Alliance for American Manufacturing to conduct an assessment of three major issues related to federal investment in transportation infrastructure: competitiveness, job creation, and procurement.

“A safe, world-class transportation infrastructure,” the report concludes, “can create new jobs through greater efficiency, increased competitiveness, and more overall demand.”

 

Political bits                        

House

Florida 2nd Congressional District:  Attorney Gwen Graham (D-FL) in a debate with her Republican opponent this with week said she would oppose Nancy Pelosi's candidacy for the party's top leadership slot.

Iowa 4th Congressional District:  An internal poll for Rep. Steve King’s (R-IA) campaign shows King leading Jim Mowrer (D-IA) by a 13 point margin, 51-38.

New Jersey 3rd Congressional District:  A Monmouth University poll finds Tom MacArthur (R-NJ) leading Aimee Belgard (D-NJ), 51 percent to 41 percent.

New Hampshire 1st Congressional District:  New England College’s weekly automated poll shows former Rep. Frank Guinta (R-NH) leading Rep. Carol Shea-Porter (D-NH) by a slim 46 percent to 44 percent margin.

New Hampshire 2nd Congressional District:  The same New England College poll shows challenger Marilinda Garcia (R-NH) trailing Rep. Annie Kuster by just three points, with Kuster leading 46 percent to 43 percent.

Senate

Alaska: Sen. Mark Begich (D-AK) raised $1.9 million in the third quarter and had $1.2 million cash on hand.

Arkansas: Sen. Mark Pryor (D-AR) raised more than $2.2 million in the third quarter and had more than $1 million cash on hand.

Colorado:  Ebola emerged as an issue in a debate between Sen. Mark Udall (D-CO) and Rep. Cory Gardner (R-CO). Udall said they should follow the advice of "doctors and the health-care professionals," while Gardner called for an immediate traffic ban on all travel from West African countries where the Ebola virus is spreading.

Kansas:  The AFL-CIO sent a mailer to 94,000 union members in Kansas, which focuses on the issue of Senator Pat Roberts's (R-KS) residency in the state. It features a Wizard of Oz-style yellow-brick road leading to the U.S. Capitol, with the words, "Pat Roberts, he's not in Kansas anymore" underneath.

Kentucky: Senate Minority Leader Mitch McConnell (R-KY) raised $3.2 million in the third quarter and had $5.2 million cash on hand.

Louisiana: Sen. Mary Landrieu (D-LA) raised $2.7 million in the third quarter and had $3.5 million cash on hand, while Rep. Bill Cassidy (R-LA) raised $2.5 million and had $4.4 million cash on hand.

Michigan: Rep. Gary Peters (D-MI) raised $2.3 million in the third quarter.

North Carolina: Thom Tillis (R-NC) raised approximately $3.4 million in the third quarter, although still less than Senator Kay Hagan’s (D-NC) $4.9 million third-quarter haul.

Virginia: Sen. Mark Warner (D-VA) raised $2 million in the third quarter and had more than $8 million cash on hand.  In a bizarre development, Warner's Republican opponent - former RNC Chair Ed Gillespie - announced on Thursday that he was no longer buying television advertising in the closing weeks of the campaign, certainly not a good sign for his campaign.

Governor

Wisconsin: According to a new Marquette University poll Gov. Scott Walker (R-WI) and former Trek executive Mary Burke (D-WI) are tied at 47 percent apiece.

A LOOK AHEAD

The House and Senate are in recess next week

WASHINGTON BY THE NUMBERS

$131 - Median price per square foot for new single-family homes in the Mid-Atlantic region—a 52-percent premium over the national median—according to a report from the National Association of Home Builders.

2,058 lbs - Weight of the winning gourd at the Safeway World Championship Pumpkin Weigh-off, held Oct. 13 in Half Moon Bay, California.

THEY SAID WHAT?

“When I say I’m never running for public office in New Jersey again, I mean: I’m never running for public office in New Jersey again. The only job left for me to run for is United States Senate, and let me just say this: I would rather die than be in the United States Senate.” -- Gov. Chris Christie, addressing the annual conference of the state NAACP (CBS News)

WASHINGTON HUMOR

"A new study estimates that only 3.4 percent of Americans will vote in the midterm elections next month. But on the bright side, 100 percent will still complain about the results." – Jimmy Fallon

 

 

 Steven C. LaTourette, President | 202.559.2600

McDonald Hopkins Government Strategies LLC
101 Constitution Avenue NW, Suite 600 East, Washington, D.C. 20001 

www.mcdonaldhopkinsgs.com

IMPORTANT NOTICE:

Although McDonald Hopkins Government Strategies LLC is owned by the law firm McDonald Hopkins LLC, McDonald Hopkins Government Strategies is not a law firm and does not provide legal services. Accordingly, the retention of McDonald Hopkins Government Strategies does not create a client-lawyer relationship and the protections of the client-lawyer relationship, such as attorney-client privilege and the ethics rules pertaining to conduct by lawyers, do not apply.

 

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