Labelling fiasco is a bitter pill to swallow
Patients in US have little recourse when ‘defective’ generics cause them harm
THE US Supreme Court recently struck down the decision and award of a state of New Hampshire court in favour of a patient, ruling 5-4 that patients do not have a right to claim against generic pharmaceutical manufacturers for the “defective design” of medicines.
The issue in this case was whether a person who is injured by the side effects of a generic drug can sue the manufacturer on the ground that the generic drug, taking into account the information on the product label, is unreasonably dangerous.
It was common cause that the injuries suffered by the patient, Ms Bartlett ( Mutual Pharmaceutical Co v Bartlett ), were appalling, namely third degree burns over most of her body associated with Stevens-Johnson Syndrome and toxic epidermal necrolysis. All agreed that these conditions are recognised, but rare, adverse events linked to the non-steroidal anti-inflam- matory medicine in question, sulindac, and that the label of the medicine did not disclose the possible occurrence of these adverse events.
At the relevant time, however, Mutual Pharmaceutical’s sulindac product and product label were in accordance with the requirements of the Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA). It is important to note that in terms of this legislation, a generic manufacturer in the US may not unilaterally make changes to a medicine’s formulation or label. In con- trast, the originator/brand-name manufacturer of a medicine is permitted to update its warning labels as and when it becomes aware of new safety risks prior to obtaining FDA approval.
The court found that because the FDA had approved the sulindac product and the label, a state court could not impose damages for harm from using the product.
The decision in Mutual Pharmaceutical Co was in alignment with the court’s 2011 finding in PLIVA v Mensing that generic manufacturers could not be held liable for failing to warn patients about the side effects of a medicine because they are required by federal law to use the same safety label as the brand-name version of the medicine.
With about 80% of all medicines dispensed in the US being generics, recourse by patients in the event of harm has been severely limited.
Undoubtedly this is a victory for generic manufacturers in the US, but are there risks to patients of similar court decisions in SA?
The registration, labelling and postregistration pharmacovigilance requirements for medicines are governed by the Medicines and Related Substances Act in SA. The Medicines Control Council (MCC) is the statutory body charged with the regulation of medicines.
There are some important differences between the regulatory framework in the US and SA.
Although generic manufacturers will be guided by the content of the originator safety information and other contents of the originator medicine package insert, there is no legal requirement in this country for the generic package insert to mirror the originator package insert. In fact, the generic package insert wording should always differ due to the originator having copyright in its package insert and it may also reflect different approved indications. By way of example, some indications may still be under patent protection and therefore cannot be included in the generic insert.
Importantly, neither the originator nor the generic manufacturer may change its package insert without the prior approval of the MCC.
In terms of the MCC’s guidelines, in the event that a pharmaceutical manufacturer (originator or generic) becomes aware of an adverse reaction to its medicines, the MCC, through its National Adverse Drug Event Monitoring Centre, must be notified immediately and an application for the amendment of the package insert should be submitted together with the originally approved insert, a proposed amended insert and motivation for the amendment. In the event that the adverse drug reaction is severe, the MCC has made provision for urgent safety updates to package inserts or for “dear doctor” alert letters to be sent to healthcare professionals.
In short, as generic manufacturers bear their own responsibility for the formulation and labelling of medicines registered by them with the MCC and for adverse event reporting in respect of such medicines, they do not have any protection from claims similar to that created by the FDCA in the US.
Good news for South African patients. Or is it?
A serious challenge for both industry (originator and generic) and for patients in SA is the amount of time it takes for package insert changes to be approved by the MCC. At present, a normal package insert amendment may take longer than three years to be approved and approval for an urgent package insert amendment may take six to 12 months.
During the approval period — other than in the most serious cases where a “dear doctor” letter is called for — updated safety and other information about a medicine is not being communicated to patients and healthcare professionals.
It is somewhat cold comfort that South African patients are able to sue generic manufacturers for damages under the Consumer Protection Act or the law of delict in the event of harm caused by an undisclosed danger of a generic medicine. Surely patients (and manufacturers) would prefer for the MCC to have permitted the danger to have been timeously disclosed to the public, prior to the harm occurring.
DOUBLE WHAMMY FOR PATIENTS The court found that because the FDA had approved the sulindac product and the label, a state court could not impose damages for harm from using the product