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

Susan Haigney

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

Articles

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.

GlaxoSmithKline and Pfizer Create New HIV-Focused Company

On Mar. 19, 2009, IMS, the leading provider of market research for the pharmaceutical and healthcare industries, reported that annual sales of prescriptions in the US grew 1.3% from $287.6 billion in 2007 to $291.5 billion in 2008. According to IMS, sales growth was slower in 2008 than in previous years. 

IMS cited higher demand for generic drugs, a reduced number of new products, and low consumer demand because of the economic downturn as reasons for the slow growth.

Sales for approximately half of the top grossing pharmaceutical companies were down from 2007. The two top moneymakers, Pfizer (New York) and GlaxosmithKline (London), were millions of dollars down from their 2007 sales.  Companies that saw a rise in sales included Astrazeneca (London), Hoffman-LaRoche (Paris), Lilly (Indianapolis), and Teva Pharmaceutical Industries (Jerusalem). 

Antipsychotic drugs were the most sold in overall sales through both retail and non-retail channels with lipid regulators, proton pump inhibitors, and seizure disorder medications following closely behind on the list of top selling drugs in 2008. Lipid regulators, antidepressants, ACE inhibitors, and beta-blockers were among the most widely dispensed prescriptions in 2008.

On March 19, 2009, IMS, the leading provider of market research for the pharmaceutical and healthcare industries, reported that annual sales of prescriptions in the US grew 1.3% from 287.6 billion in 2007 to 291.5 billion in 2008.

Growth of US Prescription Sales Slow in 2008

On Mar. 2, 2009, President  Obama nominated Kansas Governor Kathleen Sebelius as his new Secretary of Health and Human Services (HHS). Sebelius, who has served as governor of Kansas since 2003, was Kansas’ Insurance Commissioner from 1994-2002. Sebelius, a Democrat governor in a predominately Republican state, is expected to help facilitate bipartisan healthcare reform. “As Secretary of Health and Human Services, Sebelius will work with Democrats and Republicans alike to cut costs, expand access, and improve the quality of healthcare for all Americans,” a White House 

 states. Her nomination awaits Senate approval.

President Obama also appointed Nancy-Ann DeParle Counselor to the President and Director of the White House Office for Health Reform. DeParle was previously commissioner of Tennessee’s Department of Human Services. According to the White House press release, DeParle handled budget matters for federal healthcare programs during the Clinton administration and managed Medicare and Medicaid.

Obama stated in the release that, “Healthcare reform that reduces costs while expanding coverage is no longer just a dream we hope to achieve-it’s a necessity we have to achieve. And today, I am proud to announce key members of my team who will be critical to that effort: Kansas Governor Kathleen Sebelius for my Secretary of Health and Human Services and Nancy-Ann DeParle as Director of the White House Office for Health Reform.”

President Obama nominated Kansas Governor Kathleen Sebelius as his new Secretary of Health and Human Services (HHS).

Governor Kathleen Sebelius Nominated for Secretary of HHS

The US Food and Drug Administration has stated its considerations in regard to the three draft annexes to the International Conference on Harmonization’s Q4B document "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The draft annexes were published in late 2008 and resulted from the Q4B processes for uniformity of dosage units, dissolution tests, and sterility tests.

The draft annexes state that the pharmacopoeial texts for each individual processes (i.e., dosage units, dissolution tests, and sterility tests) from the United States Pharmacopeia, Japanese Pharmacopoeia, and the European Pharmacopoeia can be considered interchangeable. FDA, however, “might request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product, irrespective of the origin of the method.”

In regard to uniformity of dosage units, FDA states in draft Q4B Annex 6 that it “finds unsuitable for regulatory purposes  

not more than (NMT) 2% relative standard deviation (RSD)

 exception to the 25 mg/25% threshold. Accordingly, for those items below the 25 mg/25% threshold, testing by content uniformity should be performed.”

FDA comments on Annex 7, addressing dissolution tests, state “An appropriately rigorous mechanical calibration method (such as ASTM International’s ASTM E2503-07, Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus, or the procedures for Mechanical Qualification of Dissolution Apparatus 1 and 2, DPA-LOP.002, on the FDA website), when properly executed, will satisfy the current good manufacturing practice (CGMP) requirement for dissolution apparatus calibration under 211.160(b)(4) of Title 21 of the Code of Federal Regulations.”

The draft annexes can be downloaded here:

Uniformity of Dosage UnitsGeneral Chapter

The US Food and Drug Administration stated its considerations in regards to the three draft annexes to the International Conference on Harmonization's Q4B document.

FDA Comments on ICH Q4B Draft Annexes

-In a letter to Acting Comptroller General Gene Dodaro dated Nov. 19, 2008, Congressman Joe Barton (R-TX) requested that the US Government Accountability Office (GAO) review the US Food and Drug Administration’s handling of the highly publicized tainted-heparin scare that occurred in 2007 and 2008. Congressman Barton is a ranking member of the US House of Representatives Committee on Energy and Commerce.

Concerns raised by Barton include whether FDA thoroughly investigated the heparin situation and whether the agency has been completely forthcoming with its findings. Barton cites potential discrepancies in information provided by FDA in regards to three reported patient deaths. Barton suggests in the letter to GAO that statements made in the press by FDA that heparin was linked to the deaths of three patients potentially contradict information provided by FDA to Barton. “FDA classified the cause of death from heparin as only ‘possible’ in two of those cases, and ‘unassessable’ in the third case,” Barton states. According to Barton’s letter, Baxter Healthcare Corporation (Deerfield, IL), the manufacturer of the heparin in question, performed its own investigation into the deaths and concluded that the three deaths were unlikely to be a result of heparin use.

Also in question is FDA’s potential lack of follow-up investigations, including interviewing clinical staff and the failure to use medical reporting databases other than the FDA’s Adverse Events Reporting System. In the Nov. 19 letter, Barton states his concern that FDA may not have thoroughly investigated reported deaths because the agency “did not follow up to interview clinical staff or Baxter for further details about each of these cases. In addition, FDA told Minority Committee staff the agency did not access other [adverse drug reaction] databases…”  

The letter states that Barton believes FDA may not have made certain information regarding the investigation public and that conflicting information makes it unclear if heparin made by American Pharmaceutical Partners (APP, Schaumburg, IL) is safe. “Out of the 16 allergic reaction heparin death reports received by FDA with lot numbers, the only case in which FDA determined that the cause of death from heparin infusion was ‘probable’ involved a heparin drug made by American Pharmaceutical Partners,” Barton states. 

The congressman expresses his concern that the heparin situation may indicate that FDA has not improved its drug safety system as it promised to do in 2007 hearings before the Subcommittee on Health and the Subcommittee on Oversight and Investigations. “The apparent gaps in FDA assessment and public communication about the cause(s) of heparin deaths raise questions about whether these FDA changes have actually resulted in real improvement in drug safety oversight,” states Barton in his letter to GAO. Barton hopes “GAO’s review will determine the strengths and weaknesses in FDA’s response to the heparin drug safety problem, and will make recommendations on what FDA could do better in dealing real-time with an emerging drug safety problem in the future.”

 Early in 2008, FDA investigated reported adverse drug affects associated with the use of the blood thinner heparin. In March 2008, FDA found the contaminant over-sulfated chondroitin sulfate in the active pharmaceutical ingredient produced by a Chinese manufacturer for Baxter.

For additional information on the heparin contamination, visit:

In a letter to Acting Comptroller General Gene Dodaro dated November 19, 2008, Congressman Joe Barton (R-Texas) requested that the US Government Accountability Office (GAO) review the US Food and Drug Administration's handling of the highly-publicized, tainted heparin scare that occurred in 2007 and 2008.