Tablets & Capsules

TC0517

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B Tablets & Capsules May 2017 11 packaging How the new political climate could affect pharmaceutical packaging Edward J. Bauer Edward J. Bauer and Associates With business people now in charge, the federal government may finally look to blister packaging and better labeling to improve health outcomes and reduce costs. The first target should be treatment of chronic diseases. ig political change is remaking previous certainties, and people of all political views can see that healthcare is going to change. One early attempt—repealing or amending the Affordable Care Act (ACA)—failed. But something new will likely take its place eventually. There is new leadership at both Health and Human Services (HHS) and the Veterans Administration (VA), and a new FDA commissioner is on the way. The changes at these organizations will have a huge effect on how healthcare is delivered to patients. Furthermore, there are prominent business people in key federal positions, and a physician now runs HHS. I expect them to take a fresh look at healthcare and perhaps experiment with new ways to improve it and reduce costs. In addition, insurance companies—wiser from their experience with the ACA's exchanges—may now embrace the idea that pharmaceutical packaging can reduce the cost of treating chronic illnesses in our aging population. That spending is larger than in any area of healthcare delivery. Regulation is also likely to undergo major change, although no one knows exactly how. The new adminis- tration has discussed giving faster approval to new facili- ties and expansions. That would allow new and novel processes to be brought to market more easily and quickly. The president's order that two regulations must be eliminated for each regulation added is itself new and novel. Since when has governmental oversight entailed eliminating regulations? The approach could even lead to scrutiny of the FDA's "Guidance for Industry" documents, which have become de facto regulations. Figure 1 Most prevalent chronic conditions in adults (18 and older) in 2010 Hypertension (high blood pressure) Hyperlipidemia (high blood cholesterol or triglyceride levels) Allergies, sinusitis and other upper respiratory conditions Arthritis Mood disorders (depression and bipolar disorder) Diabetes (Type 1 and Type 2) Anxiety disorders Asthma Coronary artery disease (includes myocardial infarction/heart attack) Thyroid disorders Chronic obstructive lung disease and bronchiectasis 26.7% 3.5% 4.0% 5.3% 6.2% 6.7% 9.5% 10.6% 13.0% 13.5% 21.9%

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