Pharma Companies Can’t Afford to Make These 5 Mistakes

Pharmaceutical companies bear heavy responsibilities. The world looks to Big Pharma to research and develop new generations of drugs—some of which stand to save thousands or even millions of lives and help patients manage debilitating conditions. They also look to pharma to manufacture those drugs to exacting standards and to distribute them fairly and ethically to the entire world.

The world is watching, but regulators are also watching. Pharma companies labor under some of the most exacting regulations in the world. And with good reason—with millions of lives on the line and hundreds of jurisdictions to cross, the stakes could hardly be higher. It’s in everyones’ interest that pharma gets it right.

So no pressure. Right?

According to Dickson, today’s pharma companies, from the major players to the up-and-comers, can’t afford to make these five mistakes as they march us into a healthier future.

  1. Quality Control Failures

  2. Failure to Adapt to Regulations

  3. Approval Roadblocks for New Chemicals

  4. Failure to Adapt to Emerging Markets

  5. Failure to Innovate

  6. Conclusion

Quality Control Failures

Nothing betrays the promise of a lifesaving medication like a bad batch, manufactured or stored under non-compliant conditions and revealed to be compromised when it reaches the end-user.

Quality control failures can also result in failed compliance audits. Regulatory boards can withhold certification and bring production to a halt.

Pharma companies can guard against quality control failures by:

  1. Taking quality control seriously, with full-time quality experts on staff so that the buck stops with someone.

  2. Take environmental monitoring seriously, deploying top-of-the-line data loggers and excursion alerts according to a well-thought-out plan of action.

Basic data loggers can keep an accurate record of the conditions—temperature, humidity, pressure, etc.—under which medications are manufactured, transmitted, and stored. The logger won’t alert you, however, if a shipment of medications overheats while on the open sea and arrives at its destination unsellable.

Pharma companies should consider investing in intelligent, Cloud-based data loggers, both to protect their products and to easily track and generate reports to prove compliance with regulations and prevent costly interruptions.

Failure to Adapt to Regulations

The pharmaceutical industry is one of the most heavily regulated industries and with good reason. Ineffective drugs could be ineffective as a treatment for debilitating or life-threatening conditions. Tainted drugs could even cause health crises of their own.

Pharma companies need to invest in compliance professionals who can keep abreast of all changes in the regulatory landscape that apply to them. It’s too much to juggle outside-the-box R&D, airtight manufacturing, and scanning the deep pages of the news for ill-publicized regulatory changes. No one may notice until a failed audit shuts production down.

The regulatory landscape is also responsive to political forces. Big changes accompanied the health care debate of 2008 that lead to the Affordable Care Act, while politics can change the direction of regulatory bodies like the FDA in the U.S. and the WHO globally. As they map out their regulatory compliance plan, pharma companies can’t afford to take their eyes off the politics. Contingencies need to be built in to respond to any curveballs a governing bureau might throw at them.