CLINICAL TRIALS
DISCLOSURE: Under the FDAAA, basic results from clinical trials have
to be posted on the
Clinicaltrials.gov database and can be used by the
US regulator to request labelling changes for approved medicines
Safety issues to the fore
In 2008, pharmaceutical companies came under increasing pressure to do more to ensure the
medicines they put on the market are as safe as they can be. Ian Schofi eld assesses the impact of new
US drug safety legislation and examines Europe’s plans for strengthening its pharmacovigilance system
P
ossibly the most signifi cant event of 2008 Under the law, the FDA is expected to develop benefi ts outweigh the risks. It can include
in the drug safety area was the coming a systematic approach to the management of a a medication guide, a patient pack insert, a
into force of the US Food and Drug medicine’s benefi t-risk ratio throughout its life communication plan, elements to ensure safe
Administration Amendments Act (FDAAA). cycle, especially in the post-authorisation stage. use, and a timetable for assessing the REMS.
This gives the FDA unprecedented powers It now has greater powers to demand, and Drug approval will be withheld until the REMS
to require post-authorisation safety studies monitor, safety-related post-marketing studies is in place.
and changes to product labelling, including the and labelling changes for drugs and biologics. When post-approval studies are required,
ability to impose fi nes for non-compliance with The ability to request such studies is not the FDA and the company will agree a
post-approval studies. new for the agency; what is novel is that it can schedule for carrying out the studies, and
In Europe a new, two-year work programme now impose fi nancial penalties of up to the company will submit periodic reports on
came into play under the European Risk $10 million if companies fail to comply with progress with the research.
Management Strategy, which is intended to post-authorisation study requirements. Another aim of the FDAAA is to widen
ensure that the safety of drugs placed on the And the agency has not been slow in making public access to clinical trial results. Among
market is constantly monitored throughout use of its new-found powers. Since March, it other things, from September 2008 sponsors
their life cycle. Further improvements to the has approved 13 risk evaluation and mitigation have to post “basic results” from all clinical
pharmacovigilance system are also expected strategies (REMS), and as of late September, trials of approved drugs in the federal
soon in the form of new EU legislation. it had issued 21 letters to companies asking government’s
Clinicaltrials.gov database. These
This greater emphasis on pro-active safety for clinical trials, or epidemiology or other results include patient demographics and
measures will have signifi cant effects on both population-based studies, to address post- baseline characteristics, primary and secondary
sides of the regulatory divide, in both the US approval safety issues. outcomes, points of contact and certain
and the EU, where regulators and companies The FDA has also required safety-related agreements between the sponsor and the
are having to set aside resources to meet the labelling changes on four occasions, in all cases principal investigator; they can be used by the
new requirements. for classes of drugs: conventional antipsychotics, FDA to ask for labelling changes.
The FDAAA was signed into law by fl uoroquinolones, erythropoiesis-stimulating So what does the introduction of the
outgoing President George W Bush on agents and TNF inhibitors. FDAAA mean in practice? One result for
September 27th, 2007. It contained at least REMS are a very important aspect of the pharma fi rms has been the need to shift
200 specifi c provisions, of which more than FDAAA, and are used to manage a known resources towards areas such as post-
100 require agency action, including reports to or potential serious risk associated with a marketing research, epidemiology, safety
Congress, public notices, guidance documents medicine or a biological product. The FDA monitoring and risk management, including
and new regulations. The safety provisions can require a REMS for a new product if it REMS. This means that companies are likely
of the law took effect on March 25th, 2008. believes one is necessary to ensure that its to fi nd that product life cycle management
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