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

Susan Haigney

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.

Articles

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.

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.