usa: speeding up drug approval

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WHO: Counterfeit pharmaceuticals

Counterfeit pharmaceuticals are a worry for healthworkers in many countries, not all of them developing (see p984). The gravity of the problem has been assessed by athree-day meeting at WHO headquarters in Geneva.

Increasing steadily in volume and variety over the pastdecade, commerce in counterfeit drugs is now estimated bythe International Federation of PharmaceuticalManufacturers’ Associations to be running at somewherebetween 12 and 15 billion dollars a year (about 10% of worldtrade in pharmaceuticals).Dr J. F. Dunne, director of WHO’s division of drug

management and policies, stressed the need for sustp; -nedvigilance. In many developing nations there was productionof often rather poor replicas of well-known and widelymarketed products but "nobody is in any doubt that indeveloped countries highly organised crime is involved", headded. Some counterfeits are imitations close to the original,some are simply dilutions of active constituents; others haveno effect at all; yet others are dangerous, even lethal. Manyhave packaging identical with the real thing. A notoriousexample was the deaths of children in Nigeria given whatappeared to be a paracetamol cough mixture. Instead ofpropyleneglycol this contained diethyleneglycol, an

industrial solvent."Distribution of pharmaceuticals must be as direct as

possible from the manufacturer to the recipient", Dr Dunnesaid. "The problem is ubiquitous and very diverse. Why thisterrible crime, this murderous assault on the sick, is notcapturing more public attention is something that concernsand worries us."

Alan McGregor

USA: Speeding up drug approvalDan Quayle, the US Vice-President and Dr Louis

Sullivan, Health and Human Services Secretary,announced on April 9 that the Food and DrugAdministration is implementing four initiatives to speed updrug approval and improve the drug review process. Thefirst initiative is accelerated approval, whereby drugs can beapproved as soon as their safety and effectiveness can bereasonably established. For such approval, the FDA will use"surrogate endpoints" for efficacy. Human efficacy studieswill continue after marketing approval. Under this

programme, approval time could be reduced by as much asone to three years for "breakthrough" drugs. Under theparallel-track initiative, experimental therapies will be madeavailable to AIDS patients as early as possible in the drugdevelopment process. This policy will permit AIDSpatients who are unable to participate in controlled clinicaltrials access to experimental drugs. Initially aimed at AIDS,this policy may be evaluated for other serious diseases suchas cancer and Alzheimer’s disease. The safety testingharmonisation scheme will allow the FDA to accept animal

safety data from the European Community and Japan (andvice versa). This proposal will shorten development time bysix months or more and reduce the number of animals usedfor testing. Under the fourth initiative, the FDA will hireoutside experts to review certain routine applications fornew drugs and biological materials. In general, these will besubstances whose review is not expected to pose majordifficulties-for example, those similar to ones alreadyapproved. Groups likely to be processed in this way include

those for which the FDA has an application backlog: theanti-allergy, anti-infective, anti-inflammatory, or analgesicagents. The FDA is seeking qualified organisations as

participants in this programme. The Administration willretain final approval authority.

"These initiatives follow through on FDA’s commitmentmade last November [Lancet 1991; 338: 1449], as

recommended by the President’s Council on

Competitiveness, to provide earlier access to important newdrugs, ease unnecessary regulatory burdens and strengthenUS competitiveness", said Dan Quayle. However, there isconcern about the proposals. "This represents a really sickkind of grandstanding on the part of Vice-President Quayleto make it appear that he has caused FDA to do things theyhave been doing for some time", said Dr Sidney Wolfe,director of Public Citizen’s Health Research Group. DrWolfe believes that outside reviewers might have conflicts ofinterest. Earlier Dr Wolfe had pointed out that the USPharmaceutical Manufacturers’ Association gave$185 000to the Presidential election campaign of George Bush andDan Quayle, and to the Republican Party.

Syed Rizwanuddin Ahmad

Australia: New pharmaceutical regulations

The pharmaceutical industry in Australia is governed byActs and regulations that cover manufacturing industrygenerally and by at least another eleven Acts and sets ofregulations, at national and state level. No industry is moreclosely scrutinised or regulated than this, says the AustralianPharmaceutical Manufacturers’ Association (APMA). Itwill be even more strictly regulated if recommendations bythe Trade Practices Commission are implemented.

In its draft report released in March, the Commissionpaid some credit to the industry’s success at self-regulation,but nonetheless made recommendations that would tightenit. The Commission’s 43 recommendations affect the

industry, the medical and pharmacy professions, andconsumers. The most important of these in relation tolabelling and prescription provide that labels must carrygeneric names in stipulated typeface size, style, and colourimmediately above the brand name; that the federal

Therapeutic Goods Administration (TGA) and NationalHealth and Medical Research Council (NHMRC) act tosimplify warning statements on labels; that all instructions topharmacists be written in plain English, that the NHMRCexamine the feasibility of placing cautionary notes onunscheduled and Schedule 2 and 3 drugs (some availableover-the-counter) advising older people to consult a

pharmacist or doctor on appropriate dosage; and that theAustralian Drug Evaluation Committee produce a list ofgeneric drugs for which there might be difficulties withbio-equivalence and that these drugs be identified in thePharmaceutical Benefits Book issued to all doctors.

Federal regulatory bodies have long been criticised forinordinate delays and unduly restrictive policies in theapproval of new drugs for clinical use. The Commissionrecommends that the Pharmaceutical Benefits AdvisoryCommittee (PBAC) meets more frequently or even sits "formore than two days at each meeting to ensure thatsubmission backlogs do not develop"; that the PBACconsults specialists with appropriate knowledge and

experience when particular drugs are evaluated for clinicaluse; that the Government reviews the membership of thePBAC to ensure better representation of specialists in drug