More than 400 eminent scientists and public health experts from around the world have come together to endorse a new initiative to eradicate polio by 2018. The Scientific Declaration on Polio Eradication, published on 11 April, stated that an end to polio is scientifically feasible and achievable. Read more »
Archive for the 'Global Health' Category
The US Orphan Drug Act of 1983 defines a rare disease as one that affects fewer than 200,000. There are nearly 7000 rare diseases affecting nearly 30 million—or nearly one in 10—Americans, according to the National Organization for Rare Disorders (NORD).
The National Institutes of Health (NIH) reports that approximately 80% of rare diseases are genetic in origin; about half affect children. The challenges of facing a chronic, disabling, severe, or even life-threatening disease is compounded by difficulties in receiving an accurate diagnosis, and the lack of therapies to address the condition.
For the past six years, the last day in February has been designated Rare Disease Day. First observed in Europe in 2008 by the European Rare Disease Organization, the initiative expanded to the US in 2009. In 2012, more than 60 countries participated.
This year, events will be held worldwide on Feb. 28 to bring the cause of rare diseases to the attention of patients, the public, the medical profession, and policy makers. For example, the NIH is sponsoring a two-day conference for researchers and policymakers, including FDA representatives, to raise awareness of rare diseases, bring stakeholders closer together, coordinate policy actions between nations, and emphasize rare disease research and the search for new therapeutics.
The Orphan Drug Act provides tax credits and marketing incentives for sponsors to develop products for rare diseases. Since 1983, the number of applications submitted and products designated as orphan drugs has continued to grow. More than 400 drugs and biologic products for rare diseases have been approved. In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983.
Drug makers have financial incentives to develop orphan drugs. A 2012 report from Thomson Reuters, The Economic Power of Orphan Drugs, estimated the orphan-drug market at the end of 2011 at $50 billion globally, or 6% of total pharmaceutical sales. However, a compound annual growth rate (CAGR) of 25.8% for 2001 to 2010, compared to a 20.1% CAGR for a matched group of non-orphan control drugs, and an increasing number of orphan-drug approvals, suggests that the growth rate of orphan drugs will exceed that of non-orphan control drugs over the next 30 years, according to the report. Because many orphan drugs are biologics, they are less susceptible to generic competition than small-molecule drugs.
The impact of the smaller population needing the orphan drug is offset by the high cost of the drugs. In fact, the Thomson Reuters study found that 29% of orphan drugs have annual sales greater than $1 billion, about the same percentage as non-orphan drugs.
While the Orphan Drug Act has spurred the development of life-saving and life-improving therapies for individuals with rare diseases, it also has provided financial incentives for drug companies to invest in these narrow specialties. However, as the sponsors of Rare Disease Day point out, there is still much work to be done.
President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation. So how has the pharmaceutical industry responded?
A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world. The credit goes to public health authorities and medical experts who challenged a provision blocking production of vaccines with the preservative thimerosal, the formulation necessary for efficient vaccine distribution in developing countries. Banning thimerosal in vaccines “would be a tragedy” that put millions of children at risk, stated GAVI (Global Alliance for Vaccines & Immunization) director Seth Berkley in the New York Times (Jan. 17, 2013). Read more »
Once upon a time in the world of healthcare, the only competition for a pharmaceutical company was other pharmaceutical companies.
Times have changed. Pharma companies are now competing with many nontraditional players in the healthcare arena, including electronic and mobile health firms, retailers, financial services companies and IT firms. Healthcare is no longer about just making a new medicine, but about creating greater value for patients, providers and payers, and encouraging a more active and healthy lifestyle.
In PharmTech, we often talk about manufacturing innovations, such as new dosage forms or more efficient manufacturing techniques, but today I’m going to look at some of the innovations that have been made in the healthcare industry as a whole. Read more »
The head of the Association of the British Pharmaceutical Industry has issued a stark warning about the state of the UK’s pharmaceutical industry. In particular, concerns have been raised about the lack of new medicines being used by the UK’s National Health Service (NHS), which has affected the profits of the pharmaceutical industry and led to a decline of R&D in the country. Read more »
The end of October saw chaos in the Caribbean and then on the east coast of the US, particularly in New York and New Jersey (the location of some of PharmTech’s offices) after hurricane Sandy hit.
The pharmaceutical industry has also been affected by the storm, with several big companies delaying the announcements of their third-quarter financial results. On a consumer and patient-level, medicinal supplies have been affected in the US by looting and power outages affecting the filling of prescriptions. Read more »
The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.
In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.
As the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart, according to an announcement from HHS’s Office of the Assistant Secretary of Preparedness and Response. According to the announcement, HHS has awarded three-year contracts to all five US-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. HHS will choose the vaccine strains to be stockpiled, and expects that with vaccine seed stock already in hand, the government will be able to respond to a flu pandemic more quickly. Read more »