FDA seeks more authority amid meningitis outbreak
Excerpt:The head of the Food and Drug Administration asked Congress Wednesday for more authority to police pharmacies like the one that caused a fatal meningitis episode, even as lawmakers questioned why the company didn't do more with its existing powers. FDA Commissioner Margaret Hamburg called for new laws to clarify her company 's authority to crack down on companies like the New England Compounding Center, which distributed polluted pain injections that have actually sickened more than 460 Americans and caused 32 deaths. Members of the House Energy and Commerce Committee invested most of the first hearing on the episode questioning state and federal regulatory authorities about why they didn't act faster against the company. A timeline constructed by the committee's Republican personnel showed that the FDA and the Massachusetts board of pharmacy examined the pharmacy more than a lots times in the past years.
Keywords:
pharmacies Hamburg pharmacy compounding fungal meningitis inspections Margaret Hamburg FDA Commissioner officials Vanderbilt University Medical Center drugs steroid Massachusetts terrible tragedy Cliff Stearns President Obama federal law Obama administration Fred Upton federal government yes or no Diana DeGette prepared testimony grand poobah circuit judge methylprednisolone acetate crazy quilt loved ones spinal cord My family clean rooms constitutional rights pharmaceutical companies criminal investigation new laws the fifth amendment New England Disease Control contamination questions pain month defer sickened heartbroken two-tier system problems revoke droplets the pharmacyPeople:
Margaret Hamburg
Overall Sentiment: -0.0544845
Relevance: 0.970679
Sentiment | Quote |
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-0.121442 | Hamburg told lawmakers that the problems uncovered in inspections were "very serious," ... |
-0.018666 | "The challenge we have today is that there is a patchwork of legal authorities that oversee the regulatory actions we can take," said Hamburg, ... |
-0.0733732 | Hamburg said that when her agency tries to intervene in those cases they face a "crazy quilt," ... |
0 | Hamburg to answer simple "yes or no" ... |
-0.252622 | "No, I'm saying it's very hard to know if any one action we might have taken would have stopped this terrible tragedy," Hamburg said. ... |
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Mr. Cadden
Overall Sentiment: -0.164826
Relevance: 0.447736
Sentiment | Quote |
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0.0386955 | Cadden told lawmakers, "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment." |
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Eddie Lovelace
Overall Sentiment: -0.0868411
Relevance: 0.355734
Sentiment | Quote |
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-0.107705 | "My family is bitter, we are angry, we are heartbroken and devastated. I come here begging you to do something about the matter," Lovelace said. ... |
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Rep. Diana DeGette
Overall Sentiment: -0.371104
Relevance: 0.327097
Sentiment | Quote |
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-0.22888 | "We have to figure out how to give you the jurisdiction to do what you need to do ... and these inconclusive answers are not helping us," said Rep. Diana DeGette, ... |
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Rep. Fred Upton
Overall Sentiment: -0.219384
Relevance: 0.315949
Sentiment | Quote |
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-0.178079 | "I was stunned and angered to learn that an inspection of the NECC by the FDA and the Massachusetts board of pharmacy over 10 years ago identified contamination in the very same drug at issue in the current outbreak," said Rep. Fred Upton, ... |
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Rep. Cliff Stearns, R-Fla.
Overall Sentiment: -0.724764
Relevance: 0.302713
Sentiment | Quote |
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0.173939 | "You're the grand poobah of the FDA and I'm asking you, `could you have prevented this tragedy?' and you're saying you couldn't have because you don't have jurisdiction," said Rep. Cliff Stearns, R-Fla., ... |
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President Obama
Overall Sentiment: 0
Relevance: 0.300015
Stearns
Overall Sentiment: -0.189617
Relevance: 0.27947
Sentiment | Quote |
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-0.139313 | "Mr. Cadden, what explanation can you give the families who have lost their loved ones, and those who are gravely ill, for the actions of your company?" asked Stearns, ... |
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Key:
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Additional Info:
Organization: Food and Drug Administration
Overall Sentiment: -0.0271861
Relevance: 0.772541
Organization: House Energy and Commerce Committee
Overall Sentiment: -0.10601
Relevance: 0.441513
Organization: Massachusetts board of pharmacy
Overall Sentiment: 0
Relevance: 0.371064
Organization: Centers for Disease Control
Overall Sentiment: -0.2309
Relevance: 0.320554
Organization: Obama administration
Overall Sentiment: -0.183037
Relevance: 0.318022
Organization: Congress
Overall Sentiment: 0.132858
Relevance: 0.315815
Organization: federal government
Overall Sentiment: 0.0154779
Relevance: 0.301365
StateOrCounty: Massachusetts
Overall Sentiment: -0.0881699
Relevance: 0.391728
City: Framingham
Overall Sentiment: 0
Relevance: 0.312445
HealthCondition: meningitis
Overall Sentiment: -0.415729
Relevance: 0.455877
FieldTerminology: federal law
Overall Sentiment: 0
Relevance: 0.318721
Drug: methylprednisolone
Overall Sentiment: 0.223987
Relevance: 0.308931
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Provided Keywords:
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- diana degette
- Food and Drug Administration
- fred upton
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- lovelace
- margaret hamburg
- meningitis
- New England
- President Obama
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