Advocacy at a Glance

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

• FY 15 Continuing Resolution to Go into Effect October 1. The President signed the CR and the government will be funded from October 1 through December 11, roughly the first 10 weeks of the new fiscal year.  FDA will have the same level to spend as in FY 14, minus a few dollars taken from every government budget line to fund emergency program needs during this period (e.g., ramping up the government effort against Ebola). The agency will not be able to start new programming that was not active at some level in FY 14, although it is often unclear how this rule will be applied and whether it will hinder any FDA initiatives. There was only one specific mention of FDA in the CR: anomaly language permitting FDA to collect user fees for drug compounding facilities. A fuller explanation is contained in the attached OMB report.

• After the CR Expires in December. When Congress returns for the lame duck session after the election, it will need to decide whether some or all of the appropriations bills can be adopted. Otherwise, the federal government will need to be funded by CR for some further duration, likely either February 15 or March 30. Meantime, appropriations committee staff are working during recess to ready the appropriations bills. A consolidated omnibus bill would be the most likely -- with several bills or all of the bills wrapped into one. If a further CR is needed it will likely be because of political considerations or a failure to agree on more controversial programs or policies.

• Three Senators Call for Increased FY 16 Funding for NARMS. Senators Feinstein, Gillibrand, and Warren have written President Obama to ask for $15 million for the National Antimicrobial Resistance Monitoring System (NARMS), a near doubling of its current budget. NARMS tracks antibiotic resistance in foodborne pathogens and is a collaboration of FDA, CDC, and the Department of Agriculture. The monies would be used to significantly expand the monitoring capacity of the program and make it commensurate with the need for quick, actionable information. The numbers behind the problem: an estimated 48 million American have a foodborne illness each year. An estimated 128,000 of them are hospitalized and about 3,000 die. The annual cost of foodborne illness in the US is $75 billion.

• FDA Dedicates Its New Biodefense Laboratory Complex at White Oak. After years of planning, FDA will now have the facilities to carry out its many responsibilities for biodefense and homeland security. In particular, FDA is charged with working with companies and government agencies to evaluate and approve new medical countermeasures that would be needed if there is a biological, chemical, or radiological attack. While only anthrax has been used in an actual attack on US soil, there are an array of possible biological agents and toxins against which protection is needed. In addition, FDA has major responsibilities for medical products to respond and prevent outbreaks from emerging infectious diseases, such as Ebola. A thanks to Representatives Hoyer and Sarbanes from the Maryland Congressional delegation who attended.