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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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| 16 October 2013 | By Alexander Gaffney, RAC
Regulation is, at its core, about the mitigation of unacceptable risk. Sometimes that takes the form of denying approval to products for which risks outweigh any conceivable benefits. Other times it means keeping a close eye on a product through postmarketing studies. And in still others, it means finding ways to reduce potential and avoidable harms to patients through various methods.
The now-classic example is the institution of risk evaluation and mitigation strategies (REMS) and its predecessor programs such as RiskMAP. For some drugs with teratogenic risks, for example, FDA requires that anyone taking the drug engage in patient counseling and take/use birth control.
But in other cases, drugs can be reformulated to remove-or at least reduce-the risk of a negative attribute being expressed. And when it comes to opioids, demand for a product that reduces the risk of addiction or overdosing is in high demand as deaths and injuries from the drugs reach epidemic levels in some parts of the country. Pressure on FDA to better control use of the drugs has been high, but counteracted by some patient pain advocates who say regulators need to ensure fair access to the drugs for those who need them to be able to function.
Having found themselves in between a rock (legislators looking for more restrictions) and a hard place (patient advocates seeking continuity of access), regulators now seem to be pursuing a third option: standardized reformulation tactics.
On 15 October 2013, the National Institute for Pharmaceutical Technology and Education (NIPTE) said it had been awarded a $499,000 two-year contract to "examine formulation effects on abuse deterrence properties in solid oral dosage forms of opioids."
The intent, the group said, is to investigate how the active and inactive ingredients in a product, as well as how a drug is composed and manufactured, can limit attempts to abuse it. Current abuse methods generally involve manipulating a drug's physical properties in order to obtain rapid access to the effects of the drug.
For NIPTE, success would be beneficial to industry, regulators and patients alike.
"NIPTE's goal is to increase science and engineering-based understanding of this area so that novel state-of- the-art technologies can be developed and science-based regulations can be implemented," it said in a statement. "These technologies will also enable new drug discoveries to be brought to market faster with less variability, higher predictability of performance and at a significantly lower cost."
FDA has recently begun instituting new regulatory requirements for manufacturers of opioid products. In July 2012, it announced new class-wide REMS policies for long-acting and extended release (LA/ER) opioid products. In January 2013, it said it could "incentivize" abuse-deterrence studies for opioid products, noting that there is currently no "one-size fits all" approach to the development of abuse-deterrent technologies. And in September 2013, FDA announced it would require additional studies, trials and labeling changes for some opioid analgesic products to better emphasize their proper use.
But while Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research (CDER), said that the one-size-fits-all approach may be currently lacking, NIPTE's efforts could soon result in a better sense of how some approaches could be standardized.