Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry, according to a Mar. 12, 2010 announcement in 

FDA launched the Transparency Task Force in June 2009 with a transparency blog and website, which constituted the first phase of the project. The second phase involved two public meetings held in June 2009 and November 2009 to garner feedback from industry and the general public. The overall goal is to develop recommendations for making the agency’s “activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information,” according to an agency press release on the subject. The agency is expected to issue draft proposals soon regarding how it will increase its transparency in the long term.

Before it issues draft proposals, the agency would like to hear additional comments from industry. FDA recommends that industry read or listen to a series of sessions that were held with industry representatives in January 2010. The audio files and transcripts are available at 

FDA is particularly interested in recommendations about how it can:
·        Train and educate regulated industry about the FDA regulatory and guidance-development processes
·        Maintain open channels of communication with industry routinely and during crises
·        Provide useful and timely answers to industry questions about specific regulatory issues

Comments are due on Apr. 12, 2010 and can be submitted at www.regulations.gov.
  
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FDA Enters the Blogosphere with New Transparency Task Force (

Articles

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

FDA Transparency Initiative Moves to Phase Three

The World Health Organization (WHO) released 

 this week for the treatment of malaria. The organization also published the first-ever guidelines for procuring safe and efficacious antimalarial drugs. 

 takes into account the recent development of artemisinin-based combination therapies (ACTs). The medicines could be ineffective if not used properly, according to a WHO press release. The new guidelines emphasize testing before treatment and add a fifth ACT-dihydroartemisinin plus piperaquine-to the list of recommended treatments. WHO also is recommending the removal of oral artemisinin-based monotherapy from the market to prevent growing drug resistance.

In addition, "WHO now recommends diagnostic testing in all cases of suspected malaria,” said Robert Newman, director of the WHO Global Malaria Program, in the press release. “Treatment based on clinical symptoms alone should be reserved for settings where diagnostic tests are not available.”

In 2008, only 22% of suspected malaria cases were tested in 18 of 35 African countries that reported the cases because most clinics had to rely on microscopy, according to the press release. Today, Rapid Diagnostic Tests (RDTs) “can reliably demonstrate the presence or absence of malaria parasites in the blood and can be performed at all levels of the health system, including community settings,” according to the press release. RDTs support WHO’s goal to improve malaria-endemic countries’ quality of diagnostic services.

The second part of the WHO announcement involves the first-ever release of guidelines on good procurement practices for artemisinin-based antimalarial medicines. Based on the latest, internationally agreed-upon standards, the new guidelines include a 16-step checklist to guide the selection and procurement of safe and effective medicines that meet global quality standards.

"Pharmaceutical markets in malaria-endemic countries are often unregulated and national authorities need practical help to assess the quality of malaria medicines before they buy them," said Andrea Bosman, coordinator of the Medicines and Diagnostics Unit  at WHO's Global Malaria Program, in the press release. "Procurement channels are highly fragmented and so there are too many antimalarials of varying quality on the market."

According to WHO, malaria causes 860,000 deaths every year; 85% of these deaths are among children. 

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

WHO Releases New Malaria Treatment and Drug-Procurement Guidelines

The US Food and Drug Administration and the European Medicines Agency (EMA) are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products. A primary part of the new process includes US and EU regulatory acceptance of a single annual report from sponsors that manufacture these drug products, according to a  

Orphan and biologic drugs typically are developed to treat rare medical conditions. FDA and EMA unveiled the collaboration in recognition of World Rare Disease Day (February 28). As of Feb. 28, 2010, manufacturers no longer have to submit one annual report to FDA and one to EMA-they can produce a single report for their orphan-designated products.

“This process provides benefits for both agencies,” said Timothy Coté, director of FDA’s Office of Orphan Products Development, in the press release. “Additionally, it reduces the duplication involved for sponsors in reporting to two separate regulatory agencies.”

The agencies noted that the single annual report submission is voluntary and applies only to sponsors who have obtained orphan status for their product from both FDA and EMA. The agencies plan to exchange the reports electronically through a secure portal.

The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.

FDA and EMA Allow Single Annual Report for Orphan Drugs

Less than a week after president Obama proposed a spending freeze on non-security related federal programs, the FDA released its fiscal year 2011 budget request, calling for a 23% increase. The FDA is asking for a total of $4.03 billion in FY 2011 “to promote and protect public health,” according to an 

The FDA’s FY 2010 budget included a 19% increase over FY 2009 and totaled $3.28 billion. The new proposed budget, which would begin 1 October 2010, would include a $146-million increase in budget authority and $601 million in industry user fees. Of these user fees, approximately $667 million would be derived from the Prescription Drug User Fee Act (PDUFA) and, if the related legislation is passed, $38 million would come from human generic drug fees. If the President’s spending freeze goes through, this overall  budget increase would enable the FDA  as a non-security discretionary federal program  to have a budget of $4.03 billion for the fiscal years 2011, 2012 and 2013.

“The budget request reflects the FDA’s resolve to transform food safety practices, improve medical product safety, protect patients, and modernize FDA regulatory science to advance public health,” says the release. FY 2011 funding would also go toward the agency’s new regulatory authority over tobacco products, including cigarettes (see 

, “FDA Opens Center for Tobacco Products”).

Specifically, FDA intends to focus FY 2011 funds on four initiatives, according to the agency release: 

Transforming food safety (+ $318.3 million): FDA will set standards for safety, expand laboratory capacity, pilot track-and-trace technology, strengthen its import-safety program, improve data collection and risk analysis, and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

Protecting patients (+ $100.8 million): FDA will support the safety of drugs, devices, and vaccines, as well as the nation’s blood supply. The agency will also be able to increase inspections to “improve the security of the supply chain and reduce the potential for harm” with its medical product safety initiative, according to the agency press release.

Advancing regulatory science (+ $25 million): FDA will begin to strengthen its core scientific capacity to realize the benefits of recent discoveries and technologies. For example, with improved scientific infrastructure, the agency may work to establish improved pathways to product development and approval for new medical-treatment technologies.

Tobacco (+ $215 million): With an increase in tobacco user fees, FDA will to continue to implement the Family Smoking Prevention and Tobacco Control Act. 

The FY 2011 Health and Human Services (HHS) budget also includes $302 million for “ongoing pandemic influenza preparedness activities” within the Centers for Disease Control and Prevention, the National Institutes of Health (NIH), theFDA, and the Office of the Secretary. In addition, remaining balances from the $7.65 billion that Congress appropriated to HHS last June for H1N1 swine-flu and pandemic influenza preparedness and response would carry over to the FY 2011 budget. These balance funds would specifically go toward HHS development of “cell-based and recombinant vaccines, antivirals, respirators, and other activities to help prepare for future potential pandemics,” according to the budget proposal.

Of note, the proposal calls for $39 million in budget authority for the FDA to consolidate at its headquarters at the White Oak (MD, USA) location and $112 million to repair and maintain FDA-owned facilities throughout the US.

Finally, NIH would be appropriated an increase of $1 billion for a total of $32.2 billion to support innovative biomedical research projects.

 to read President Obama’s full FY 2011 budget proposal for HHS. 

 to read a related blog post: "Federal Spending Freeze Could Threaten Supply-Chain Security”

Less than a week after president Obama proposed a spending freeze on non-security related federal programs, the FDA released its fiscal year 2011 budget request, calling for a 23% increase.

FDA requests another major year-over-year budget increase

Less than a week after President Obama proposed a spending freeze on nonsecurity-related federal programs, the US Food and Drug Administration released its fiscal year 2011 budget request, calling for a 23% increase. FDA is asking for a total of $4.03 billion in FY 2011 “to promote and protect public health,” according to an 

FDA’s FY 2010 budget included a 19% increase over the FY 2009 budget and totaled $3.28 billion. The new proposed budget, which would begin Oct. 1, 2010, would include a $146-million increase in budget authority and $601 million in industry user fees. Of these user fees, approximately $667 million would be derived from the Prescription Drug User Fee Act and, if the related legislation is passed, $38 million would come from human generic-drug fees. If the president’s spending freeze is enacted, then this overall  budget increase would enable FDA-as a nonsecurity discretionary federal program-to have a budget of $4.03 billion for the fiscal years 2011, 2012, and 2013.

“The budget request reflects the FDA’s resolve to transform food-safety practices, improve medical product safety, protect patients, and modernize FDA regulatory science to advance public health,” said the press release. FY 2011 funding would also go toward the agency’s new regulatory authority over tobacco products, including cigarettes (see 

“FDA Opens Center for Tobacco Products”

FDA intends to focus FY 2011 funds on the following four initiatives: 
 1. Transforming food safety ($318.3 million). FDA will set standards for safety, expand laboratory capacity, pilot track-and-trace technology, strengthen its import-safety program, improve data collection and risk analysis, and begin to establish an integrated national food-safety system with strengthened inspection and response capacity.

2. Protecting patients ($100.8 million). FDA will support the safety of drugs, devices, and vaccines, as well as the nation’s blood supply. The agency will also increase inspections to “improve the security of the supply chain and reduce the potential for harm” with its medical-product safety initiative, according to the agency press release.

3. Advancing regulatory science ($25 million). FDA will begin to strengthen its core scientific capacity to realize the benefits of recent discoveries and technologies. For example, with improved scientific infrastructure, the agency may work to establish improved pathways to product development and approval for new medical-treatment technologies.

4. Tobacco ($215 million). With an increase in tobacco user fees, FDA will to continue to implement the Family Smoking Prevention and Tobacco Control Act. 

The FY 2011 US Department of Health and Human Services (HHS) budget also includes $302 million for “ongoing pandemic influenza preparedness activities” within the Centers for Disease Control and Prevention, the National Institutes of Health (NIH), FDA, and the Office of the Secretary. In addition, remaining balances from the $7.65 billion that Congress appropriated to HHS last June for H1N1 swine-flu and pandemic-influenza preparedness and response would carry over to the FY 2011 budget. 

These balance funds would specifically go toward HHS development of “cell-based and recombinant vaccines, antivirals, respirators, and other activities to help prepare for future potential pandemics,” according to the budget proposal. 
 Of note, the proposal calls for $39 million in budget authority for FDA to consolidate at its headquarters at the White Oak, Maryland, location and $112 million to repair and maintain FDA-owned facilities throughout the US.

Finally, NIH would receive an increase of $1 billion for a total of $32.2 billion to support innovative biomedical research projects.

 President Obama’s full FY 2011 budget proposal for HHS.

“Federal Spending Freeze Could Threaten Supply-Chain Security”

Less than a week after president Obama proposed a spending freeze on nonsecurity-related federal programs, the US Food and Drug Administration released its fiscal year 2011 budget request, calling for a 23% increase.

FDA Requests Another Major Budget Increase

The US Food and Drug Administration issued a 

, in late January.  The document is meant to assist manufactures developing drug products that have the potential to be abused, as defined by the Controlled Substances Act (21 USC 811b-c). 

These types of drugs typically affect the central nervous system, are chemically or pharmacologically similar to other drugs  with known abuse potential, or produce psychoactive effects such as sedation, euphoria, or mood change, said the guidance.

The document includes a definition for “abuse potential” and provides information on what to include in abuse-potential assessments, including a proposal for scheduling and study design. Such assessments must be provided to FDA with the sponsor’s new drug application (NDA) for any drug product that has abuse potential.

Information to be submitted with the NDA, according to the draft guidance, includes a summary, interpretation, and discussion of abuse-potential data provided in the NDA; a proposal and rationale for placing (or not placing) a drug into a particular schedule of the Controlled Substances Act; all primary data related to the abuse-potential characterization of the drug, organized under chemistry, preclinical pharmacology, animal behavioral and dependence pharmacology, pharmacokinetics−pharmacodynamics, human abuse potential laboratory studies, clinical-trial data relative to abuse and dependence potential, integrated summaries of safety and efficacy, and foreign experience with the drug.

The US Food and Drug Administration issued a draft guidance for industry, Assessment of Abuse Potential of Drugs, in late January.