Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion. 

The proposed budget also includes $1.97 billion in user fees, including $583 million in proposed new user fees. The budget request includes “inflationary increases for FDA user fee programs, as authorized by law.”

“The resources in this budget will allow FDA to perform its fundamental public health responsibilities in new and more efficient ways. Our budget also supports industry efforts to innovate and bring new products to market that will benefit American patients and consumers and strengthen our economy,” states FDA Commissioner Margaret A. Hamburg, in the 

Included in the proposed FDA budget is an additional $363 million earmarked for projects that protect patients, including addressing and detecting risks from products manufactured in China. “The budget contains new resources to increase FDA’s capacity to detect and address risks in products and ingredients manufactured in China before they result in harm to Americans,” states Hamburg.

The proposed FY 2013 budget sustains the current level of staffing and activities for the Medical Countermeasures Initiative, which is designed to meet national security and public health requirements for medical countermeasures (MCM) readiness. FDA will continue to partner with industry and academia to shorten MCM development timelines and improve success rates.

Health and Human Services Deputy Secretary Bill Corr, in a 

, states the proposed Health and Human Services budget “continues to support President Obama’s historic push to stamp out waste, fraud, and abuse in our health care system…and our budget helps reduce the deficit by $366 billion over 10 years, almost all of which comes from reforms to Medicare and Medicaid.”

PhRMA expressed concerns about the President’s proposed budget and the changes to Medicare in a 

, “Medicare Part D is working well for seniors. Due to competition, costs continue to be far below initial projections. We should not disrupt this successful program.”

PhRMA also responded to the budget’s handling of data protection, biosimilars, and patents. “We are also troubled by the President’s proposal to reduce data protection for innovative biologic medicines, which is critically important to the development of cutting-edge medicines so needed by patients… The biosimilars provision of the health care reform law-the only provision in the law to garner strong bipartisan support-achieves an essential balance. It provides appropriate incentives to support future medical advances. It supports high-value jobs that are critical to our nation’s economic recovery. And, it provides savings by creating the first pathway for federal regulators to approve biosimilars.”

“Similarly, patent settlements are a vital aspect of a patent owner’s ability to protect intellectual property. Restricting such settlements, which already are subject to review by the Federal Trade Commission and the Department of Justice, could discourage pro-consumer settlements, which often bring generics to market years before patent expiration. Without settlements, costly litigation could keep these generics from being available to patients for years.”

Articles

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.

White House's 2013 Budget Includes FDA Increases

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and programs for human generic drugs and biosimilar biological products.

FDA modeled the proposed user fee programs on the PDUFA created by Congress in 1992. Commissioner Margaret A. Hamburg, PhD, stated in a FDA 

 that the PDUFA has “ensured a predictable, consistent, and streamlined premarket program for prescription drugs.” Under the programs, the pharmaceutical industry helps to fund a portion of FDA’s drug review activities by paying fees. In return, FDA agrees to process applications in a particular timeframe as well as other performance goals.

Commissioner Hamburg stated, “At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion.” With the recommended programs, FDA would be able to continue to conduct timely reviews of critical prescription drugs, provide communication with small and emerging companies, promote the use of electronic data, and advance drug development for rare diseases.

The generic-drug market has been growing and applications for new generic drugs have been on the rise. FDA stated in the press release that the proposed Generic Drug User Fee program would ensure that the agency had the necessary funding to process new generic drug applications. The proposal includes review timeframes that would reduce the review backlog and provides a “commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year.”

FDA intends for fees included in the Biosimilar and Interchangeable Products User Fee program to generate revenue in the near-term and support development-phase meetings with sponsors. FDA stated that the proposed biosimilar program would spur competition in the biologic drug market by allowing companies to develop alternative products. According to FDA, a biosimilar is “a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biologic product and the reference product in terms of safety, purity, and potency of the product.”

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.

FDA Recommends Three Drug User Fee Programs

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain. The TIRF REMS program is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.

“This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research in a 

. FDA hopes to limit the risk of misuse, overdose, abuse, and complications related to TIRF medicines, which include the brand names Abstral, Actiq, Fentora, Lazanda, and Onsolis. The program will ensure that TIRF drugs are prescribed and dispensed only to appropriate patients and will prevent inappropriate conversion between fentanyl products.

Prescribers, patients, and pharmacies will begin using the program beginning in March 2012, but until then the current individual REMS programs will continue to be used. Those already enrolled in established individual REMS for TIRF products will automatically be transitioned to the shared program. Patients who receive TIRF medicines in inpatient situations (e.g., hospitals and hospices) will not be required to enroll in the program, nor will the doctors that prescribe TIRF drugs in inpatient situations. However, patients receiving the medicines on an outpatient basis are required to be enrolled.

Safety Concerns and Shortages Challenge Pharma

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.

FDA Creates Shared REMS System for TIRF Medicines

Arnesto Segredo of Miami, Florida, was sentenced on February 18, 2010, to 70 months in prison for conspiring to divert prescription drugs, according to a 

 from US Attorney’s Office.  Segredo was convicted in August 2009 of diverting drugs and diverting drugs in interstate commerce.

According to prosecutors, from 2000 through 2002, Segredo had unlicensed wholesale suppliers regularly ship him boxes of the human growth hormones Serostim and Nutropin AQ. Segredo operated the Miami-based prescription-drug wholesaler Life Extension Institute, from 2000-2001, which was not licensed to distribute prescription drugs in the state of Florida.  He later ran another Miami drug-wholesaler company, Genendo Purchasing Organization, that was licensed in Florida in 2001.

Serostim is an FDA-approved injectable drug used for the treatment of AIDS-wasting syndrome, and Nutropin AQ is FDA-approved for treatment of growth hormone deficiency.  According to a press release from the US Attorney’s Office, evidence showed that the counterfeit Nutropin AQ distributed by Segredo entered the drug-supply chain and caused bodily harm to a child that received the drug.

The Prescription Drug Marketing Act prevents prescription drug diversion and the distribution of counterfeit, stolen, or substandard drugs and requires that wholesalers be licensed by state authorities.

Arnesto Segredo of Miami, Florida, was sentenced to 70 months in prison for conspiring to divert prescription drugs.

Drug Diverter Sentenced to 70 Months in Prison

On Sept. 25, 2009, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline’s (GSK) Pandemrix and Novartis’s Focetria.

Pandemrix is an adjuvanted vaccine that contains an antigen of H1N1 2009 and a proprietary adjuvant system AS03. Jean Stephenne, president of GlaxoSmithKline Biologicals, stated in a company press release that, “This positive opinion means that Pandemrix will now be immediately reviewed for approval by the European Commission, which is an important step closer to helping reduce the impact of the pandemic.” 

Focetria is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against the influenza A (H1N1) virus. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, stated in a Novartis press release that “several recent clinical trials suggest that just one dose of pandemic vaccine can protect healthy adults, which means that now the vaccine can be provided to more people than if two doses were needed.” 

CHMP made the recommendation of the two vaccines based on a “mock-up” approach of previously approved flu vaccines. CHMP is recommending  “a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and children from six months of age.” According to a press release, EMEA is awaiting further data on a single dose for adults and has requested that the manufacturers of the vaccines monitor the safety of the vaccines as they begin being used by the public. 

NIAID Announces “Encouraging” Early Results of H1N1 Vaccine in Children

H1N1 Vaccine Trial Data Still Needed for High-Risk Groups

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

EMEA Recommends Two H1N1 Vaccines for Authorization

Pharmaceutical giants GlaxoSmithKline (GSK) and Pfizer announced on April 16, 2009 that they are joining forces to tackle HIV. They are creating a  company that will specialize in the research, development, and access of HIV treatments by combining existing products, new products already in each company’s pipeline, and existing not-for-profit access programs. Research and development (R&D) of new treatments will be a central focus of the new company, and R&D services will be contracted directly from GSK and Pfizer. 

The new company’s main goal is to become an industry leader with a combined product portfolio that includes 11 products already in the market, including GSK's Combivir (lamivudine, zidovudine), Kivexa (abacavir/lamivudine), and Pfizer's Selzentry/Celsentri (maraviroc tablets), and six products currently in development. “By combining Pfizer’s and GlaxoSmithKline’s complementary strengths and capabilities, we are creating a new global leader in HIV and reaffirming our ongoing commitment to the treatment of the disease,” stated Jeff Kindler, Pfizer CEO, in a company press release.

Access to HIV treatments will also be an important focus for the new company. A statement on the HIV Futures company 

  assures that “not-for-profit pricing for HIV medicines will continue for those countries most in need, and the new company will continue to facilitate new voluntary licenses to diversity production and expand capacity in these markets.” The company will also address the continuing need for research into the global treatment of children living with HIV.

Both GSK and Pfizer have HIV drug access programs already in place around the world. “HIV remains a global threat with increasing incidence and viral resistance. This new company will be better placed to meet these challenges and improve access to treatments,” stated Andrew Witty, GSK chief executive officer, in a company press release. “The new company can reach more patients and accomplish much more for the treatment of HIV globally than either company on its own,” stated Kindler. 

More information regarding the new HIV-focused company can be found at 

Pharmaceutical giants GlaxoSmithKline (GSK) and Pfizer announced on April 16, 2009 that they are joining forces to create a new HIV-focused drug company.