{"id":1863,"date":"2013-04-08T05:04:00","date_gmt":"2013-04-08T00:04:00","guid":{"rendered":"http:\/\/www.policymed.com\/drug-shortages-despite-gains-many-drugs-are-still-in-short-supply\/"},"modified":"2018-05-06T14:26:06","modified_gmt":"2018-05-06T09:26:06","slug":"drug-shortages-despite-gains-many-drugs-are-still-in-short-supply","status":"publish","type":"post","link":"https:\/\/www.policymed.com\/2013\/04\/drug-shortages-despite-gains-many-drugs-are-still-in-short-supply.html","title":{"rendered":"Drug Shortages: Despite Gains, Many Drugs are Still in Short Supply"},"content":{"rendered":"<p><span style=\"font-family: arial,helvetica,sans-serif;\">A recent article from <a href=\"http:\/\/www.bloomberg.com\/news\/2013-03-14\/drug-deficit-turning-india-s-claris-into-target-real-m-a.html\">Bloomberg<\/a> noted that \u201cas shortages of sterile injectables persist, the makeup of that part of the industry is in flux.\u201d\u00a0 To address the current marketplace struggles, \u00a0Mylan has agreed to buy Agila Specialties, the injectables unit of <a href=\"http:\/\/links.mkt1985.com\/ctt?kn=154&ms=NDgwMDk3NAS2&r=MjQwNzYxNzc3MTAS1&b=0&j=MTQ2MTgyODEwS0&mt=1&rt=0\" target=\"_blank\" rel=\"noopener\">Strides Arcolab<\/a>, for $1.6 billion, and analysts think Claris Lifesciences could be next, saying \u201cit is a matter of supply and demand.\u201d\u00a0\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Claris has five (5) FDA-sanctioned manufacturing facilities in Ahmedabad, and an analyst tells\u00a0<em>Bloomberg<\/em> it might be worth about $500 million.\u00a0 Claris has \u201ca ready-made facility,\u201d Ranjit Kapadia, an analyst at Centrum Broking in Mumbai, said in a telephone interview. \u201cThere\u2019s a scarcity of injectable facilities in the global space, and in the U.S. there\u2019s a shortage of injectable products, so this may lead to an acquisition.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Claris was itself barred from selling its products in the U.S. after the FDA found it was producing contaminated drugs and failed to fully investigate the cause, according to a 2010 <a title=\"Open Web Site\" href=\"http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/2010\/ucm233010.htm\">warning letter<\/a> from the agency. Claris was told in August 2012 that it had <a title=\"Open Web Site\" href=\"http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/2010\/ucm315542.htm\">addressed<\/a> the complaints and was allowed to resume U.S. sales. Last month, it got FDA approval for its ninth drug.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">There are shortages of sterile injectable drugs in the U.S. and growing demand, but only a limited number of FDA-approved plants to make them. \u00a0\u201cManufacturing injectable drugs requires sterile facilities to protect against unwanted contaminants, and the FDA has cracked down on manufacturers that fail to meet its safety requirements,\u201d Bloomberg noted.\u00a0 FDA\u2019s office of manufacturing and product quality sent 22 <a title=\"Open Web Site\" href=\"http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/default.htm\">warning letters<\/a> in 2012, up from 19 the previous year, according to its website.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Recently, the Food and Drug Administration (FDA) added Pfizer Inc.\u2019s tuberculosis treatment rifampin to its list of drugs in short supply, the latest in a growing number of spottily available TB medications, reported <a href=\"http:\/\/www.reuters.com\/article\/2013\/03\/25\/us-pfizer-tuberculosis-idUSBRE92O0MO20130325\">Reuters.<\/a>\u00a0 The FDA noted in a post on its website on Monday that the injectible antibiotic will be in short supply until the end of June. The cause of the shortage is a manufacturing delay, it said.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Rifampin is one of the most potent and widely used TB drugs, and its shortage comes amid an increased prevalence of the disease around the world, though TB rates in the United States fell to an all-time low last year.\u00a0 In a letter to physicians dated March 18, Pfizer said a number of vials of the medication may not meet the specifications for drug potency, and exhibited a change in color from the expected red powder to brown or black.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The complexity of the manufacturing process means rivals can\u2019t switch quickly to produce medicines that are in short supply, making it difficult to plug shortages, the FDA says on its <a title=\"Open Web Site\" href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/DrugShortages\/ucm050796.htm\">website<\/a>. Currently, 241 drugs — most of them injectable medicines — are in short supply, according to a <a title=\"Open Web Site\" href=\"http:\/\/www.ashp.org\/menu\/DrugShortages\/CurrentShortages\">list<\/a> on the website of the American Society of Health-System Pharmacists.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The largest producer in the U.S., Hospira, continues to struggle to get its plants to full capacity after running into FDA compliance problems. \u00a0In fact, Hospira recently <a href=\"http:\/\/www.massdevice.com\/news\/fda-shakes-down-hospira-facility-3-week-inspection\">disclosed an FDA inspection<\/a> of its Rocky Mount, N.C., facility, saying 5 agency inspectors reviewed the facility for 3 weeks and issued a Form 483 warning flagging 20 problems at the plant.\u00a0 As a result of the inspection, Hospira recalled the lots of 5 different products, including three lots of <a href=\"http:\/\/links.mkt1985.com\/ctt?kn=257&ms=NDc2MDg4OQS2&r=MjQwNzYxNzc3MTAS1&b=0&j=MTQzODQ1NTU2S0&mt=1&rt=0\" target=\"_blank\" rel=\"noopener\">propofol<\/a> injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">It also recalled one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection,\u00a0furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.\u00a0 The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">While companies like Hospira are facing troubles, others such as Hima Pharmaceuticals Plc reported a 19 percent rise in full-year profit, helped by strong growth in its lucrative injectables business, which has drawn interest from several bidders, according to <a href=\"http:\/\/www.reuters.com\/article\/2013\/03\/13\/hikma-results-idUSL3N0C42BV20130313\">Reuters<\/a>.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The company, founded in 1978 in Jordan, said it expected overall revenue to increase 10 percent in 2013, with revenue in the injectables <a href=\"http:\/\/www.reuters.com\/finance?lc=int_mb_1001\">business<\/a> expected to grow in the low double-digits.\u00a0 Revenue in the injectables business rose 49 percent to $470 million, driven mainly by an 83 percent increase in sales in the United States.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Hikma\u2019s injectables business, the second-biggest supplier of generic injectables in the United States, has been able to take advantage of a drug shortage there as several generic drugmakers have been forced to cut capacity in the face of stringent regulatory scrutiny due to quality issues.\u00a0 Hikma said earlier this month it was reviewing options for the injectables business after getting several expressions of interest at a time when M&A activity in injectables is heating up.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Other Drug Shortage News<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">In other news, FDA updated that EMD Serono\u2019s Cetrorelix Acetate for Injection is no Longer Experiencing Shortages as of <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/DrugShortages\/ucm050793.htm#cetrorelix\">March 26, 2013.<\/a>\u00a0 Additionally, Otsuka <a href=\"http:\/\/www.pmlive.com\/pharma_news\/otsuka_files_new_tb_candidate_in_japan_as_shortages_worsen_469315\">recently filed<\/a> <strong>a desperately-needed treatment for resistant\u00a0 strains of TB, but reports of further shortages with one of the current mainstay therapies.\u00a0 <\/strong>Otsuka says it has now filed delamanid as a treatment for <a title=\"WHO claims $1.3bn annual funding gap for tuberculosis research\" href=\"http:\/\/www.pmlive.com\/pharma_news\/who_claims_$1.3bn_annual_funding_gap_for_tuberculosis_research_468405\">multi-drug resistant (MDR) pulmonary TB<\/a> in patients who are also being treated with a background regimen of anti-TB drugs.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">FDA also recently announced that it has fast-tracked and approved <a href=\"http:\/\/www.fiercepharmamanufacturing.com\/tags\/cook-pharmica\">Cook Pharmica<\/a>\u2019s manufacturing facility without doing a preapproval inspection so that it could begin producing a drug that is on the FDA shortage list, reported <a href=\"http:\/\/www.fiercepharmamanufacturing.com\/story\/fda-fast-tracks-plant-injectable-shortage-list\/2013-03-26\">FiercePharmaManufacturing.<\/a>\u00a0 he company did not say which drug it was or who it is manufacturing it for, but indicated it was a sterile injectable product.\u00a0 We previously noted that FDA took a similar action to approve a generic version of Johnson & Johnsons <a href=\"http:\/\/www.policymed.com\/2013\/02\/fda-strategic-plan-to-address-drug-shortages-solicitation-for-comment.html\">cancer drug Doxil<\/a> from India\u2019s Sun Pharma that it had put through a fast-track approval process.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Finally, <a href=\"http:\/\/www.ipqpubs.com\/news\/the-accelerated-recovery-initiative-on-drug-shortages-is-gaining-momentum-%E2%80%93-pilot-program-underway\/\">International Pharmaceutical Quality<\/a> (IPQ) recently reported that \u201c<a href=\"http:\/\/www.policymed.com\/2012\/09\/ftc-approves-accelerated-recovery-initiative-to-reduce-drug-shortages.html\">The Accelerated Recovery Initiative<\/a> (ARI) \u2013 an FDA\/industry partnership being coordinated by pharma data manager IMS \u2013 is gaining momentum in its effort to forecast, prevent, and mitigate the impact of drug shortages, and a pilot program is now underway.\u201d<strong>\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">At a mid-March supply chain conference in Cincinnati, Ohio cosponsored by Xavier University and FDA, IMS Commercial Effective Services Senior Principle Michael Barnes noted that the pilot program is \u201cin the early stages\u201d and is now \u201cgetting to the point at which FDA, IMS and a select number of manufacturers are beginning to test the process.\u201d\u00a0 In his presentation at the FDA\/Xavier conference, IMS\u2019 Barnes provided insights into:\u00a0\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">the common complaints from stakeholders on how drug shortages are currently handled <\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">why drug shortages occur <\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">the formation, purpose and function of ARI, and <\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">the ARI pilot and the respective roles being played by FDA, GPhA and IMS<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>A recent article from Bloomberg noted that \u201cas shortages of sterile injectables persist, the makeup of that part of the industry is in flux.\u201d\u00a0 To address the current marketplace struggles, \u00a0Mylan has agreed to buy Agila Specialties, the injectables unit of Strides Arcolab, for $1.6 billion, and analysts think Claris Lifesciences could be next, saying […]<\/p>\n","protected":false},"author":1,"featured_media":8536,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[56],"tags":[1101],"class_list":["post-1863","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-shortages","tag-new"],"_links":{"self":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1863","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/comments?post=1863"}],"version-history":[{"count":1,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1863\/revisions"}],"predecessor-version":[{"id":8538,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/1863\/revisions\/8538"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media\/8536"}],"wp:attachment":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media?parent=1863"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/categories?post=1863"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/tags?post=1863"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}