Regulating the drugs industry transparently
Authors: John Abraham
Journal: BMJ (2005)

Over the past 10-15 years, drug regulatory authorities in the United Kingdom and elsewhere have streamlined and accelerated the review of new drugs in response to claims by the pharmaceutical industry that over-regulation was stifling innovation.1,2 Despite these policies, the number of new molecular entities—a standard measure of innovation in the industry—submitted to regulatory authorities in the European Union or United States or launched on the world market has fallen overall during the past decade.3-5

Between 1993 and 2004, almost double the number of drugs were withdrawn from the market in the United Kingdom each year due to lack of safety than in the previous two decades.6 The withdrawal of rofecoxib in 2004, affecting millions of patients, remains an enormous public health issue, as do public concerns about the safety of the widely prescribed selective serotonin reuptake inhibitors.7,8

In this context the House of Commons Health Select Committee began its wide ranging inquiry into the influence of the pharmaceutical industry, publishing its findings on 5 April 2005.9 Although the committee acknowledged that the industry makes excellent contributions to medicine and the UK economy, the report also highlighted important concerns about the independence of drug regulation from the interests of the industry; the need to create conditions in which the industry will produce more drugs offering significant therapeutic advance; the industry's over-promotion of its products to doctors; our limited knowledge of drug induced illness; and the cloak of secrecy around UK regulation during the past 35 years. On 1 September 2005 the government's response to the committee's report showed serious reflection on these issues.10 The government has accepted many of the committee's recommendations, but too often its response has not gone far enough.

The committee recommended that the Department of Trade and Industry should take responsibility for representing the interests of the pharmaceutical industry, enabling the Department of Health to concentrate solely on the regulation of medicines and the protection and promotion of health. The government rejected this recommendation on the grounds that “the interests of patients and the industry are not exclusive” and that the industry's role in producing innovative medicines beneficial to health should be considered together with its economic investment in the United Kingdom. In this political context there is a considerable risk that public health will not be given sufficient priority whenever the commercial interests of pharmaceutical companies diverge from, or conflict with, health needs.

Since 1996 fewer than half of the drug innovations (new molecular entities) in the United States have offered real therapeutic advances.9 Many are “me too” drugs: minor molecular modifications of existing products. They satisfy the technical definition of innovation and seek a slice of a lucrative market, but contribute little or no therapeutic advance for patients. The House of Commons Health Select Committee recommended that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) should be more proactive in stimulating the industry to develop drugs of real therapeutic value and “therapeutic gain.” Despite recognising that the existence of a large number of “me too” drugs creates difficulties for prescribers, the government remains unwilling to direct the development of drugs towards more meaningful new treatments.

The committee also felt that the deluge of promotional material doctors receive from pharmaceutical companies is excessive and insufficiently counterbalanced by independent information, especially when the manufacturer seeks to establish a market position for a newly launched drug and patients are most at risk because little is known about the product. The government, on the other hand, believes that the industry's current self regulation of drug promotion is acceptable. Nevertheless, the MHRA may extend its vetting of promotional materials to all new molecular entities and may impose additional restrictions when new drugs are first released on to the market.

The government now seems to embrace the idea of patients reporting their own adverse drug reactions using the Yellow Card scheme that is already used by prescribers. However, the government ignored the committee's call for the Department of Health and the MHRA to investigate the extent, cost, and implications of drug induced illness in our communities and to pave the way for rational cost-benefit assessment of medicines.

Issues of secrecy, transparency, and public accountability in the drug regulatory system pervaded almost every aspect of the inquiry. The government agrees that the regulatory system should be as transparent as possible. It has promised to provide public access to information on licensing applications for individual drugs, to the data supporting authorisation for marketing, and to assessments of medicines on which regulatory action is taken. This is a considerable and welcome shift in thinking and policy, but these commitments must also be implemented in practice.

The committee recommended that the MHRA should make public the material it receives from drug companies along with its assessments as soon as they are complete. This would enable scientists and doctors to scrutinise and engage with the agency's decision making processes and would ensure that drug regulation was publicly defensible and hence more robust. The government, however, insists on reaching regulatory decisions about applications for new drug licences before allowing any public access to such information. At least, though, the government has agreed that the MHRA should be independently reviewed every four or five years.