In a course of the showdown prior the Lower House elections in Japan on September 11th, the major political parties published their "manifests". The flavor of the foreign word has been used to increase the importance of those policy documents, what essentially are just party’s pledge.
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Drug approvals and pharmaceutical affairs in Japan
01/20/07
In contrast to the chorused complains against the - as lobbyists put it - “glacier speed” of new drug approval in Japan, the chronology of Alimta shows quite the opposite. Let’s follow:
- In June 2005, it became clear that in addition to factory workers, many people living near the former factory operated by machinery maker Kubota Corp. in Hyogo Prefecture, had developed asbestos-related disorders, including malignant pleural mesothelioma. Soon similar health problems were reported in other areas such as Gifu and Nara prefectures. According to the statistics released by the Ministry of Health, Labor and Welfare, 7,924 people across the nation died of mesothelioma in the 11 years since 1995. Due to the difference in collecting the primary data in different prefecture, the actual number patients is thought to be higher and not expected to peak until 2030
- In the second half of 2005, the asbestos became a household word after an extensive coverage by the media. A package of bills aimed at providing financial support to people suffering from asbestos-linked diseases was enforced in 2006. According to the compensation scheme, the Government plans to collect 7.4 billion Yen within 4-year period starting 2007 to cover the compensation including treatment for victims and the affected families
- In November 2005, the Health, Labor and Welfare Ministry has decided to shorten the review period for a new drug to treat mesothelioma (Alimta) to one year form the average time of two years. Meanwhile, Nippon Eli Lily Japan KK has been conducting dose-finding trial from February and late Phase II trial from October 2005
- A submission for approval of Alimta in Japan was made on June 26, 2006 for treatment of malignant pleural mesothelioma in combination with cisplatin. On June 28, 2006 six manufacturers of cisplatin products applied for revision of “Indications” in the Package Inserts of theirs respective 6 products (in 10 formulations). The approval review was completed by December 7, 2006 and the Minister of Health, Labor and Welfare granted on January 4, 2007 a Manufacturing & Sale Approval to Alimta (vials 500 mg)
along the revised cisplatins. Overall, the review took only 5 months - In another speedy leg, Alimta has been given a reimbursement price
on January 19 and the company is planning to start the sales on January 22, 2007. Due to the limited pre-approval trials, as one condition for approval, the maker is obliged to recruit at lest 300 patients in Phase IV study. The drug will be initially introduced at around 400 hospitals nationwide specialized in chemotherapy
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Technorati Tags: MHLW; Japanese regulatory affairs
02/12/06
If the approval of Iressa happened to be if not a cloud, but at least cloudy, it also has a silver lining. Both in response to the public criticism and along with the newer obligations concerning the pharmacovigilance, the authorities have decided to start disclosing information on advirse events (AEs) reported for medicines approved in Japan. Although it is hardly to assume that the disclosure step has been prompted solely by the Iressa saga, yet the reaching of Iressa incidents to the general public nonetheless served as a catalyst.
Remarkably, the AEs data - previously elusive even to professionals, are now readily open to the public. Many pharmaceutical companies in Japan have fallen to third party providers to make available even for professional audience - such as physicians and pharmacists, and even the most innocent pieces of information - such as photographs of the packages, against charges and detailed registration. The Government took an opposite approach to have all the data posted at no charge and accessible without any tracking. Commendable.
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Technorati Tags: MHLW; Japanese regulatory affairs
Web site to offer information on drug side effectsThe Pharmaceutical and Medical Devices Agency on Tuesday launched a Web site that enables people to search for lists of side effects, symptoms and associated diseases brought on by a variety of medicines. The site, www.info.pmda.go.jp, includes a database of all side effects as reported by drug manufacturers. The first data to be made public by the agency was in April 2004, with accounts detailing 732 medicinal products and 2,477 related case studies that include information such as age, gender, disease, details of the side effects, the drug and other medicines taken concurrently. The site also includes case studies for the 63 people whose deaths during that period were brought on by side effects from medicines they were taking. Twelve of these deaths were linked to the lung cancer drug gefitinib, marketed as Iressa. Warnings also are included for cases in which the side effects were found to not be connected to health problems. The PMDA will make information from May 2004 onward available in due course, aiming to put a system into effect before the end of March 2008, with updates every six months. Until now, such reports were limited to cases involving previously unknown side effects, or where revisions had been made to warnings over usage. The new system was conceived of in the face of increasing complaints from citizens’ groups and others organizations demanding all the information be made public, as only 1,872 of the 25,000 or so drug-related side effects last fiscal year had been disclosed. The agency, an independent organization, has also begun posting on its Web site easy-to-understand explanations on dosage and side effects. Beginning with 54 kinds of drugs, including oral diabetes medication, the next medicines to be posted will include antirheumatic and antiasthmatic drugs. (The Daily Yomiuri, February 9, 2006, p. 3)
12/02/05
Femara - an aromatase inhibitor - is known to be submitted and currently under a review by the Japanese regulatory authorities. Yet, as distributed today by the mass media, the warnings issued by Novartis AG were forwarded to the physicians in Japan as well. As read between the lines - under the provision of the Pharmaceutical Affairs Law (PAL), any unapproved drug could be imported for individual use in Japan as long as the custom official is shown a prescription by Japanese doctor. Obviously, Femara (the name is misspelled in the original news release below) - another of the unapproved anti-cancer drugs in Japan has been imported by significant number of female patients treated domestically.
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Technorati Tags: MHLW; Japanese regulatory affairs
Swiss firm warns breast cancer drug can harm unborn children
Thursday, December 1, 2005 at 07:15 JST
TOKYO — A Swiss pharmaceutical company has decided to warn gynecologists in the United States, Japan and other countries not to prescribe women a breast cancer drug during pregnancy or before menopause, as it may harm unborn children, officials of the its Japanese associate said Wednesday.
TOKYO — A Swiss pharmaceutical company has decided to warn gynecologists in the United States, Japan and other countries not to prescribe women a breast cancer drug during pregnancy or before menopause, as it may harm unborn children, officials of the its Japanese associate said Wednesday.
Letrozole, distributed by Novartis AG under the name Femera, is commonly used to prevent relapses of breast cancer. Animal tests have proven that the drug can cause fetal abnormalities and its use in pregnant and pre-menopausal women has been banned.
11/03/05
In a rare PR move, the MHLW made publicly available through the mass media the previously adopted decision regarding changes in the approval qualification for anticancer drugs. Today Kyodo News Agency distributed in bilingual format the announcement that from April 1, 2006 the NDAs for anticancer drugs should include - along with the efficacy and safety profiles, data proving prolongation of patient life. Yet another of the Iressa aftershocks…
The new guideline from MHLW stipulates that data from Phase III studies in patients with non-small cell lung, stomach, large intestine and breast cancer should contain detailed evidences for life prolongation.
Ironically, Iressa (gefitinib) was one of the very few New Chemical Entities (NCE) to be first internationally approved in Japan and it turned into a regulator’s nightmare, as the cases of fatal interstitial pneumonia reached to the tabloids. Ever since the first news about lethal side effects of Iressa appeared in 2002, the MHLW found itself between rock and hard place: criticized for both negligence in "hastily" approving Iressa and systematically failing to approve other advanced anticancers.
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Technorati Tags: MHLW; Japanese regulatory affairs
08/28/05
Such pledges - more or less vague, have been around for years, however recently they sharpened to include more numerical targets and to reflect real needs of Japan. Such as the growing cancer epidemic. In a quite telling move, the Democratic Party of Japan (Minshuto) announced its manifest from August 16 that if won, would allocate 50-fold more funds (in the range of half billion dollars) only for anti-cancer measures. Among the major problems of economy underperformance and pension reform, it is rare a specific healthcare point of concern to earn such attention. To certain degree this is a reflection of DPJ membership - the only party to point on having physicians in its ranks.
Yet, there is no word about the sensitive point of new drug approvals. Perhaps, the last time when pharmaceutical issues gained higher visibility was in June 1998 when the Subcommittee on State Pharmaceutical Policy, belonging to the Research Committee on Basic Medical Policies of the ruling Liberal Democratic Party (LDP) published a policy report outlining the party’s vision on the government – pharmaceutical industry collaboration.
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Technorati Tags: MHLW; Japanese regulatory affairs
07/29/05
On January 8, 2004 the business press in Japan reported that the little known Division of Clinical Trial Design & Management to the Translational Research Center of Kyoto University Hospital has conducted a study on anti-cancer drugs in Japan. For this study the Division has utilized a very modest methodology by comparing the list of drugs classified as “anti-cancers” in the 2003 edition of the "Current Medical Diagnosis and Treatment” - an easy-to-read manual believed to be commonly used by the US physicians, to the medicinal products approved in Japan for treatment of cancer. In short, the conclusion pointed that 30% of anti-cancers and 40% of the products for complementary oncology therapy were not yet approved in Japan by the end of 2003.
Although reported in a highly sensational style – the title in the local English-language “The Daily Yomiuri” was “Japan bars 30% of drugs used in U.S. for cancer”, it remains unclear whether the Division actually ever published the results of the study (emails and calls to it were not returned).
Whether the publicizing the findings triggered the current flow of approvals of anticancers in Japan is debatable, however it came amid a growing tension between all players in the oncology healthcare in Japan. By early 2004 it was widely acknowledged that a number of patients have been using unapproved, but imported drugs or domestically approved but applied off-label products. In one of the most demonstrative cases, as many as 500,000 tablets of Thalidomide were imported legally in Japan by individual patients for treatment of multiple myeloma. None of the accompanying costs for the purchase, shipping and custom clearance were borne by insurers and no entity has been responsible for post-marketing surveillance. All players involved – patients, providers (practicing physicians), payers, pharmas and the regulators, were unhappy but an exit from the impasse came in late 2004 by reaching the Basic Agreement of December 15, 2004 between the Minister of Health, Labor and Welfare and the Minister of State in charge concerning so-called “Mixed payment for medical examination and treatment” – or a concurrent provision of insured and noninsured services and therapies.
As a first measure the MHLW established a working group called Committee for the Examination of the Use of Unapproved Medicinal Products (aka as Investigational Committee for Usage of Unapproved Drugs, both titles are provisional translations) which already has had five regular meetings. Full details of the system for development of unapproved drugs in Japan are included in the report of the 21st New Drug Evaluation Division Information Meeting (available online at http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=JM_I_017&Category_Code=JMI), but in brief, the authorities are asking the pharma makers to initiate clinical trials of new products or for new indications, by providing support and reducing the red tape. At the latest meeting held on July 22, 2005 the Committee adopted a recommendation for clinical development of four new products.
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Technorati Tags: MHLW; Japanese regulatory affairs