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Regintel

  • Writer: Manan Ambani
    Manan Ambani
  • Oct 28, 2021
  • 3 min read

Regulatory intelligence is the only competitive strategy for pharma(and most other industries).

A regulatory intelligence professional’s job is to know what’s happening at the agency level and get the information to the business.

Regulators don’t communicate in a way that’s easy for business to understand.

I don’t necessarily mean this in a pejorative sense.

Regulators have a job to do, which is to enforce regulations. Their job is to prevent bad things from happening, but it goes well beyond this, because regulators are also concerned with the public health. When regulations are drafted, their primary audience is other regulators. The regulations are drafted so that regulators will understand the regulations and be able to enforce the regulations. This makes perfect sense, but it’s entirely unsurprising that the process doesn’t provide much opportunity for feedback from industry. When regulations are proposed, they will speak to industry concerns, but they will also speak to public health concerns. It’s pretty rare that public health concerns are prioritized over industry concerns, and this makes perfect sense. Regulators are ultimately responsible for public health. If regulations are drafted in such a way that they protect public health, it’s fair to assume that regulators will prioritize public health over industry concerns. If regulations are drafted in such a way that they protect industry, it’s fair to assume that regulators will prioritize industry over public health. It's no mystery that regulations are drafted in such a way as to protect public health. This makes sense, but it puts a lot of pressure on industry. If pharma has a problem with a proposed regulation, it’s fair to assume that regulators will put public health first. You can lobby the regulators(and you should), but you probably won’t get very far.Because ultimately, if regulations protect public health, they’re fair. If pharma doesn’t like it, they can lobby the regulators, but they probably won’t get very far. Now, when pharma doesn’t like a proposed regulation, they can get creative. If pharma doesn’t like a proposed regulation, they can get creative by influencing public opinion. While regulation is developed by regulators, the effect of regulation is ultimately felt by patients. If pharma doesn’t like a proposed regulation, they can lobby the regulators, but they can also lobby patients. When regulations are proposed, pharma can make their plans accordingly. When regulations are proposed, pharma can make their plans accordingly. If pharma doesn’t like a proposed regulation, they can start talking to patients. To be clear, pharma can talk to patients about proposed regulations before they actually go into effect. Pharma can talk to patients about proposed regulations before they go into effect. If pharma doesn’t like a proposed regulation, they can start talking to patients about it. This puts pharma in an interesting situation. If pharma doesn’t like a proposed regulation, they can lobby the regulators, but they can also influence the public debate. If pharma doesn’t like a proposed regulation, they can start talking to patients about it. This is, of course, a roundabout way to have regulations changed. But it’s a smart strategy. If pharma doesn’t like a proposed regulation, they can lobby the regulators, but they can also use public opinion to change the regulations. Now, this strategy works because regulators are ultimately responsible for public health.

If regulators decide that a proposed regulation protects public health, it’s fair to assume that regulators will prioritize public health over industry concerns. If regulators decide that a proposed regulation protects industry, it’s fair to assume that regulators will prioritize industry over public health.

This is, of course, a roundabout way to have regulations changed.


But it’s a smart strategy.

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