The [Regulatory] Times, They Are A-Changin’


By Jacob Presson,
Research Analyst

Regulatory affairs groups in the pharmaceutical industry have been going through a fast-paced evolution over the past 10 years.  It wasn’t that long ago that these groups were almost taken for granted in the industry.  Recently, however, this role has been changing substantially from simply getting a drug approved to being involved much earlier in the development process and asked to significantly influence the final product. Continue reading



The Debate on ‘Pay-for-Delay’ and Anti-Trust Laws


By Jennifer Harrell,
Research Analyst

“Pay-for-delay” deals face increasing regulatory scrutiny, although the details of their true economic implications remain murky. These deals – often the result of painstaking litigation – allow branded drug makers to maintain market exclusivity by compensating generics manufacturers for later entry dates. Critics of these settlements argue that they deter market competition, burdening the consumer with higher drug prices. The Federal Trade Commission reports that these settlements cost consumers up to $3.5 billion in inflated prices last year. Industry leaders counter that the agreements actually save patients money because generics reach the market more quickly.  According to a recent Cutting Edge Information study, 18% of surveyed companies use pay-for-delay settlements as an exclusivity extension tactic. However, this statistic may be watered down by the off-putting public opinion ramifications, as these agreements are quickly tagged as anticompetitive. Continue reading


Price Accountability Comes to Sales Reps via Affordable Care Act

The Affordable Care Act’ (ACA) ride through legislative and judicial hurdles has focused on the high profile aspects of the law including the insurance mandate and state Medicaid responsibilities.  However, one part of the law that will have a major impact on both patients and pharmaceutical sales forces is the establishment of accountable care organizations (ACOs) that bring physicians, hospitals and pharmacies together to create a more cohesive healthcare package for patients.  This means that doctors would be made aware of potentially conflicting medications a patient may already be taking and be able to recommend a less risky course of a treatment. Continue reading


Longer regulatory approval timelines? It’s not all FDA’s fault.

Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some countries. Many companies are adding substantial numbers of regulatory affairs personnel, preferably of the very experienced variety, to deal with the increased issues. Continue reading


More Regulations, More Problems

More regulations, more problems. It’s not exactly a catchphrase yet, but it is something you might have overheard within a pharmaceutical regulatory affairs office over the past several years. The simple fact is that over the past five to ten years, guidances from agencies worldwide have started to stack up. The number of steps needed for companies to remain compliant has grown and the burden on regulatory affairs groups has increased tremendously.

In response, many pharmaceutical companies have steadily increased their regulatory affairs headcounts. Continue reading


Avoid Overly Strict or Loose Compliance Policies through Formal Feedback Mechanisms

Compliance is a necessary part of doing business (very necessary for bio/pharm), but sometimes it goes a shade too far. When asked what single factor he would change about compliance efforts at his company if he could, a compliance executive from a top pharma company responded with one word: simplification. At a previous company, the compliance team dictated SOPs for seemingly everything. These SOPs were written with a level of detail that made the process of creating, reviewing, finalizing and approving all of those control documents a significant effort.

Later he arrived at a position with a new company that applied the opposite approach. Continue reading



The Widening Talent Gap in Regulatory Affairs is a Problem for Small Pharma


By Casey Ferrell,
Senior Research Analyst

In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn’t always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals more wins.

In pharmaceutical regulatory affairs, the same is increasingly true. To the detriment of smaller players and the benefit of bigger ones, talented regulatory affairs personnel are in high demand; this seems to be driving rapidly growing salaries. Companies with deeper pockets are snatching up the best and brightest regulatory affairs professionals working, creating a talent gap in the industry, the ripple effects of which are numerous and consequential. Continue reading